FDA 510(k) Application Details - K042261

Device Classification Name

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510(K) Number K042261
Device Name MACROPORE PURICEL LIPOPLASTY SYSTEM
Applicant MACROPORE BIOSURGERY, INC.
6740 TOP GUN ST.
SAN DIEGO, CA 92121 US
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Contact KENNETH K KLEINHENZ
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Regulation Number

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Classification Product Code QPB
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Date Received 08/23/2004
Decision Date 09/20/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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