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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, Polymeric
510(k) Number K792281
Device Name USHER'S MARLEX TUBULAR MESH
Applicant
Davol, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Davol, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number878.3300
Classification Product Code
FTL  
Date Received11/13/1979
Decision Date 11/27/1979
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
Recalls CDRH Recalls
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