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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
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