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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 K072076
FOIA Releasable 510(k) K072076
Device Name CYTOPLAST PTFE SUTURE
Applicant
Osteogenics Biomedical, Inc.
4620 71st St. Bldg. 78-79
Lubbock,  TX  79424
Applicant Contact DUSTYN WEBB
Correspondent
Osteogenics Biomedical, Inc.
4620 71st St. Bldg. 78-79
Lubbock,  TX  79424
Correspondent Contact DUSTYN WEBB
Regulation Number878.5035
Classification Product Code
NBY  
Date Received07/30/2007
Decision Date 10/31/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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