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FDA 510(k), K122494, POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT
FDA 510(k), K122494, POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT
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510(K) Number: K122494
Device Name: POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT
Manufacturer: BERNARD HORWATH
Device Classification Name: Splint, Intranasal Septal
Regulation Number: LYA
Classification Product Code: 08/16/2012
Date Received: 03/27/2013
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ear Nose & Throat
Device Name: POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT
Manufacturer: BERNARD HORWATH
Device Classification Name: Splint, Intranasal Septal
Regulation Number: LYA
Classification Product Code: 08/16/2012
Date Received: 03/27/2013
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ear Nose & Throat
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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