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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 K852011
Device Name NYLAMID MESH PAD FULL & HALF
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 Number878.3300
Classification Product Code
FTM  
Date Received04/26/1985
Decision Date 06/11/1985
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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