FDA 510(k) Application Details - K052735

Device Classification Name Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)

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510(K) Number K052735
Device Name Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
Applicant LIFECELL CORP.
555 13TH STREET, NW
WASHINGTON, DC 20004 US
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Contact HOWARD M HOLSTEIN
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Regulation Number 888.3045

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Classification Product Code MBP
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Date Received 09/30/2005
Decision Date 12/28/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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