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FDA 510(k) Application Details - K133453
Device Classification Name
Device, Surgical, Cryogenic
More FDA Info for this Device
510(K) Number
K133453
Device Name
Device, Surgical, Cryogenic
Applicant
MYOSCIENCE INC
1600 SEAPORT BLVD, STE 450
NORTH LOBBY
REDWOOD CITY, CA 94063 US
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Contact
BIJESH CHANDRAN
Other 510(k) Applications for this Contact
Regulation Number
882.4250
More FDA Info for this Regulation Number
Classification Product Code
GXH
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More FDA Info for this Product Code
Date Received
11/12/2013
Decision Date
03/24/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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