FDA 510(k) Application Details - K142272

Device Classification Name

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510(K) Number K142272
Device Name SNaP Wound Care System
Applicant SPIRACUR, INC.
1180 BORDEAUX DRIVE
SUNNYVALE, CA 94089 US
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Contact Lawrence Hu
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Regulation Number

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Classification Product Code OKO
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Date Received 08/15/2014
Decision Date 11/25/2014
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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