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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 K904052
Device Name SUPRAMID EXTRA SUTURES
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 Received08/29/1990
Decision Date 10/25/1990
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
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