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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 K830768
Device Name DISPOSABLE SKIN STAPLER
Applicant
Surgeons Choice, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Surgeons Choice, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number878.4320
Classification Product Code
FZQ  
Date Received03/11/1983
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
Predetermined Change
Control Plan Authorized		 No
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