FDA 510(k) Application Details - K131523

Device Classification Name Unit, Cryosurgical, Accessories

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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
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Regulation Number 878.4350

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Classification Product Code GEH
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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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