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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 K100090
Device Name IMPLANTABLE CLIP
Applicant
GENICON
6869 STAPOINT CT., SUITE 114
WINTER PARK,  FL  32792
Applicant Contact GARY HABERLAND
Correspondent
GENICON
6869 STAPOINT CT., SUITE 114
WINTER PARK,  FL  32792
Correspondent Contact GARY HABERLAND
Regulation Number878.4300
Classification Product Code
FZP  
Date Received01/12/2010
Decision Date 02/02/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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