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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name mesh, surgical
510(k) Number K071065
Device Name ORTHADAPT BIOIMPLANT
Original Applicant
PEGASUS BIOLOGICS, INC.
6 jenner
suite 150
irvine,  CA  92618
Original Contact pamela misajon
Regulation Number878.3300
Classification Product Code
FTM  
Subsequent Product Codes
OWY   OXB   OXE  
Date Received04/16/2007
Decision Date 05/04/2007
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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