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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name clip, implantable
510(k) Number K040602
Device Name SURELINE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS
Applicant
DESIGN STANDARDS CORP.
182 CEDA RD.
P.O. BOX 1620
CHARLESTOWN,  NH  03603
Applicant Contact MICHELE LUCEY
Correspondent
DESIGN STANDARDS CORP.
182 CEDA RD.
P.O. BOX 1620
CHARLESTOWN,  NH  03603
Correspondent Contact MICHELE LUCEY
Regulation Number878.4300
Classification Product Code
FZP  
Date Received03/08/2004
Decision Date 05/10/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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