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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
Applicant
PEGASUS BIOLOGICS, INC.
10 pasteur st.
suite 150
irvine,  CA  92618
Applicant Contact muir s meinhold
Correspondent
PEGASUS BIOLOGICS, INC.
10 pasteur st.
suite 150
irvine,  CA  92618
Correspodent 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 (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
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