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FDA 510(k), K122434, MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL
FDA 510(k), K122434, MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL
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510(K) Number: K122434
Device Name: MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL
Manufacturer: MEDTRONIC XOMED
Device Classification Name: Polymer, Ear, Nose And Throat, Synthetic, Absorbable
Regulation Number: 874.3620
Classification Product Code: NHB
Date Received: 08/10/2012
Decision Date: 10/31/2012
Regulation Medical Specialty: Ear Nose & Throat
Device Name: MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL
Manufacturer: MEDTRONIC XOMED
Device Classification Name: Polymer, Ear, Nose And Throat, Synthetic, Absorbable
Regulation Number: 874.3620
Classification Product Code: NHB
Date Received: 08/10/2012
Decision Date: 10/31/2012
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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