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FDA 510(k), K080022, GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP
FDA 510(k), K080022, GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP
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510(K) Number: K080022
Device Name: GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP
Manufacturer: DEBORAH NEYMARK
Device Classification Name: Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
Regulation Number: KHJ
Classification Product Code: 01/03/2008
Date Received: 12/09/2008
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ear Nose & Throat
Device Name: GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP
Manufacturer: DEBORAH NEYMARK
Device Classification Name: Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
Regulation Number: KHJ
Classification Product Code: 01/03/2008
Date Received: 12/09/2008
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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