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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 K833698
Device Name AMER. V. MUELLER SURG. STAPLES ILA
Applicant
AMERICAN HEYER SCHULTE
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
AMERICAN HEYER SCHULTE
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.4750
Classification Product Code
GDW  
Date Received11/15/1983
Decision Date 01/25/1984
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
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