FDA 510(k) Application Details - K053611

Device Classification Name Massager, Vacuum, Light Induced Heating

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510(K) Number K053611
Device Name Massager, Vacuum, Light Induced Heating
Applicant BICELLULASE, INC.
21 PARK AVE.
NEWTON, MA 02458 US
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Contact ROBERT NAGEL
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Regulation Number 878.4810

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Classification Product Code NUV
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Date Received 12/27/2005
Decision Date 03/15/2006
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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