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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, polypropylene
510(k) Number K931614
Device Name MOPYLEN 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 Number878.5010
Classification Product Code
GAW  
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
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