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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Applier, Hemostatic Clip
510(k) Number K862696
Device Name TEMPORARY HEMO CLIP, 07-096-01/02 & APPLY FORCEP
Applicant
Downs Surgical , Ltd.
42 Industrial Way
Wilmington,  MA  01887
Applicant Contact JOHN FORSTER
Correspondent
Downs Surgical , Ltd.
42 Industrial Way
Wilmington,  MA  01887
Correspondent Contact JOHN FORSTER
Regulation Number878.4800
Classification Product Code
HBT  
Date Received07/15/1986
Decision Date 07/30/1986
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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