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FDA 510(k), K950621, BIOFILL BIOCELLULOSE DRESSING STERILE
FDA 510(k), K950621, BIOFILL BIOCELLULOSE DRESSING STERILE
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510(K) Number: K950621
Device Name: BIOFILL BIOCELLULOSE DRESSING STERILE
Manufacturer: JAMES H CONOVER
Device Classification Name: Bandage, Liquid
Regulation Number: KMF
Classification Product Code: KXA
Date Received: 02/10/1995
Decision Date: 12/26/1995
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: BIOFILL BIOCELLULOSE DRESSING STERILE
Manufacturer: JAMES H CONOVER
Device Classification Name: Bandage, Liquid
Regulation Number: KMF
Classification Product Code: KXA
Date Received: 02/10/1995
Decision Date: 12/26/1995
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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