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FDA 510(k) Application Details - K142272
Device Classification Name
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
OKO
Other 510(k) Applications for this Device
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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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