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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Implantable
510(k) Number K833704
Device Name AMER. V. MUELLER SURGICALSTAPLES-CARTR
Applicant
American Heyer Schulte
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
American Heyer Schulte
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number878.4750
Classification Product Code
GDW  
Date Received10/18/1983
Decision Date 12/29/1983
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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