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shipping:fda_import_export_information [2017/10/31 11:29]
smayr [FDA Import/Export Information]
shipping:fda_import_export_information [2017/10/31 11:29] (current)
smayr [FDA Import/Export Information]
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   * Medical Specialty: ''Ear Nose & Throat''   * Medical Specialty: ''Ear Nose & Throat''
   * Medical Device Listing (LST): ''E449176''   * Medical Device Listing (LST): ''E449176''
-  * FDA Record: [[https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=47626&lpcd=ESD]] and [[https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?rid=11708|Audina/Auditiva FDA Establishment Registration & Device Listing]]+  * FDA Record: [[https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=47626&lpcd=ESD|Main]] and [[https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?rid=11708|Audina/Auditiva FDA Establishment Registration & Device Listing]]
   * Product (Proprietary Names): ''478 BTE; 478P BTE; 478P+ BTE; AGC-o; AUDINA; Audina 675DP+; Audina Analog +; Audina Arro 2; Audina Arro 6; Audina Arro 6AD; Audina BTE D6HP; Audina BTE D6P; Audina BTE6AD; Audina BTED275; Audina Flx 4; Audina Flx 6; Audina Intuition 6; Audina Intuition 6AD; Audina IRIC 6; Audina OCTANE T; BTE 13D2; BTE D2; BTE D2HP; BTE DP; Class A; Class D; Cue; ezHEAR; FLX; FLX 2; Foundation; InstaFit; Intellio; Intuition 12; Intuition 12AD; Intuition 2; Intuition 2+; Intuition 2ER; Intuition 2FC; Intuition 2FC+; Intuition 4+; Intuition 4AD; IRIC 12; IRIC 2; IRIC 4; nVe; nVe AD; Octane; Octane 12; Octane 4; Opti Trim; Push Pull; Simplex; Simplex 2; Simplex 2P; Simplex 2P+; Simplex FC; Sparo; Sparo 12; Sparo 2; Sparo 2+; Sparo 2ER; Sparo AD; Super 60D''.   * Product (Proprietary Names): ''478 BTE; 478P BTE; 478P+ BTE; AGC-o; AUDINA; Audina 675DP+; Audina Analog +; Audina Arro 2; Audina Arro 6; Audina Arro 6AD; Audina BTE D6HP; Audina BTE D6P; Audina BTE6AD; Audina BTED275; Audina Flx 4; Audina Flx 6; Audina Intuition 6; Audina Intuition 6AD; Audina IRIC 6; Audina OCTANE T; BTE 13D2; BTE D2; BTE D2HP; BTE DP; Class A; Class D; Cue; ezHEAR; FLX; FLX 2; Foundation; InstaFit; Intellio; Intuition 12; Intuition 12AD; Intuition 2; Intuition 2+; Intuition 2ER; Intuition 2FC; Intuition 2FC+; Intuition 4+; Intuition 4AD; IRIC 12; IRIC 2; IRIC 4; nVe; nVe AD; Octane; Octane 12; Octane 4; Opti Trim; Push Pull; Simplex; Simplex 2; Simplex 2P; Simplex 2P+; Simplex FC; Sparo; Sparo 12; Sparo 2; Sparo 2+; Sparo 2ER; Sparo AD; Super 60D''.