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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 K973652
Device Name DUOCLIPPER TITANIUM CLIPS
Applicant
Scion International, Inc.
5200 Blue Lagoon Dr.,
Suite 890
Miami,  FL  33126
Applicant Contact STEPHEN CHAKOFF
Correspondent
Scion International, Inc.
5200 Blue Lagoon Dr.,
Suite 890
Miami,  FL  33126
Correspondent Contact STEPHEN CHAKOFF
Regulation Number878.4300
Classification Product Code
FZP  
Date Received09/25/1997
Decision Date 03/27/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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