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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 K840172
Device Name VENTRAL WALL DEFECT REDUCT SILO
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 Number878.3300
Classification Product Code
FTL  
Date Received01/17/1984
Decision Date 06/27/1984
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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