FDA 510(k) K003028, CYTOPLAST SUTURE; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HC, by Osteogenics Biomedical, Inc.
FDA 510(k) K003028, CYTOPLAST SUTURE; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HC, by Osteogenics Biomedical, Inc.
Device Name: CYTOPLAST SUTURE; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HC
Manufacturer: Osteogenics Biomedical, Inc.
Device Classification Name: Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
Regulation Number: 878.5035
Classification Product Code: NBY
Date Received: 09/28/2000
Decision Date: 11/24/2000
Regulation Medical Specialty: General & Plastic Surgery
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