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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
510(k) Number K003028
FOIA Releasable 510(k) K003028
Device Name CYTOPLAST SUTURE; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HC
Applicant
Osteogenics Biomedical, Inc.
3234 64th St.
Lubbock,  TX  79413
Applicant Contact CHAD BARTEE
Correspondent
Osteogenics Biomedical, Inc.
3234 64th St.
Lubbock,  TX  79413
Correspondent Contact CHAD BARTEE
Regulation Number878.5035
Classification Product Code
NBY  
Date Received09/28/2000
Decision Date 11/24/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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