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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stapler, surgical
510(k) Number K801445
Device Name SKIN STAPLER HANDLE 523700/CARTRIDGES
Applicant
EDWARD WECK, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
EDWARD WECK, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.4740
Classification Product Code
GAG  
Date Received06/20/1980
Decision Date 07/14/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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