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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name mesh, surgical
510(k) Number K973379
Device Name STERILE SUPRAFOIL SMOOTH NYLON FOIL SHEETS
Applicant
S. JACKSON, INC.
15 ROTH ST.
P.O. BOX 4487
ALEXANDRIA,  VA  22303
Applicant Contact J. JACKSON
Correspondent
S. JACKSON, INC.
15 ROTH ST.
P.O. BOX 4487
ALEXANDRIA,  VA  22303
Correspondent Contact J. JACKSON
Regulation Number878.3300
Classification Product Code
FTM  
Date Received09/08/1997
Decision Date 09/25/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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