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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 K931612
Device Name NYLAMID 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 Received04/01/1993
Decision Date 12/17/1993
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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