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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Nonabsorbable, Synthetic, Polyamide
510(k) Number K912429
Device Name N80-838 SUPRAMID EXTRA SUTURE
Applicant
S. Jackson, Inc.
15 Roth St.
P.O. Box 4487
Alexandria,  VA  22303
Applicant Contact JACKSON
Correspondent
S. Jackson, Inc.
15 Roth St.
P.O. Box 4487
Alexandria,  VA  22303
Correspondent Contact JACKSON
Regulation Number878.5020
Classification Product Code
GAR  
Date Received05/31/1991
Decision Date 10/02/1991
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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