FDA 510(k) Application Details - K111006

Device Classification Name

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510(K) Number K111006
Device Name CI-SNAP WOUND CARE SYSTEM
Applicant SPIRACUR, INC.
155-A MOFFETT PARK DRIVE
SUITE 210
SUNNYVALE, CA 94089 US
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Contact SARAH CANIO
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Regulation Number

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Classification Product Code OKO
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Date Received 04/11/2011
Decision Date 07/21/2011
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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