FDA 510(k) Application Details - K093547

Device Classification Name

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510(K) Number K093547
Device Name PINPOINTE FOOTLASER
Applicant PINPOINTE USA, INC.
3637 BERNAL AVE.
PLEASANTON, CA 94566 US
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Contact ANNE WORDEN
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Regulation Number

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Classification Product Code PDZ
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Date Received 11/17/2009
Decision Date 10/15/2010
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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