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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name clip, removable (skin)
510(k) Number K830704
Device Name ONE TIME DISPOSABLE SKIN STAPLER
Applicant
ACME UNITED CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
ACME UNITED CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.4320
Classification Product Code
FZQ  
Date Received03/07/1983
Decision Date 04/12/1983
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
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