FDA 510(k) Application Details - K071065

Device Classification Name Mesh, Surgical

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510(K) Number K071065
Device Name Mesh, Surgical
Applicant PEGASUS BIOLOGICS, INC.
6 JENNER
SUITE 150
IRVINE, CA 92618 US
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Contact PAMELA MISAJON
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Regulation Number 878.3300

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Classification Product Code FTM
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Date Received 04/16/2007
Decision Date 05/04/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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