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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 K043388
Device Name PEGASUS BIOLOGICS ORTHADAPT SURGICAL MESH
Original Applicant
PEGASUS BIOLOGICS, INC.
10 pasteur st.
suite 150
irvine,  CA  92618
Original Contact muir s meinhold
Regulation Number878.3300
Classification Product Code
FTM  
Subsequent Product Codes
OWY   OXB   OXE  
Date Received12/09/2004
Decision Date 08/05/2005
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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