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FDA 510(k) Application Details - K131523
Device Classification Name
Unit, Cryosurgical, Accessories
More FDA Info for this Device
510(K) Number
K131523
Device Name
Unit, Cryosurgical, Accessories
Applicant
C2 THERAPEUTICS
303 CONVENTION WAY
SUITE 1
REDWOOD CITY, CA 94063 US
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Contact
PETER GARCIA-MEZA
Other 510(k) Applications for this Contact
Regulation Number
878.4350
More FDA Info for this Regulation Number
Classification Product Code
GEH
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More FDA Info for this Product Code
Date Received
05/28/2013
Decision Date
08/22/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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