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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 K822963
Device Name SURGICAL PRODUCTS, SKIN STAPLE REMOVER
Applicant
TEMP-STIK CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
TEMP-STIK CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.4320
Classification Product Code
FZQ  
Date Received10/05/1982
Decision Date 11/08/1982
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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