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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 K830889
Device Name DEXON 'S' POLYGLYCOLIC ACID MESH
Applicant
Davis & Geck, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Davis & Geck, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number878.3300
Classification Product Code
FTM  
Date Received03/21/1983
Decision Date 05/09/1983
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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