FDA 510(k) Application Details - K041996

Device Classification Name Holder, Infant Position

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510(K) Number K041996
Device Name Holder, Infant Position
Applicant PLASTIC SURGERY SOLUTIONS, LLC
1150 N. 35TH AVE., STE. 490
HOLLYWOOD, FL 33021 US
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Contact PHIL CARTER
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Regulation Number 880.5680

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Classification Product Code FRP
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Date Received 07/26/2004
Decision Date 08/03/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party Y
Expedited Review



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