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FDA 510(k) Application Details - K243677
Device Classification Name
Device, Surgical, Cryogenic
More FDA Info for this Device
510(K) Number
K243677
Device Name
Device, Surgical, Cryogenic
Applicant
Pacira Biosciences, Inc.
10410 Science Center Drive, Building A
San Diego, CA 92121 US
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Contact
Niloufa Insanally
Other 510(k) Applications for this Contact
Regulation Number
882.4250
More FDA Info for this Regulation Number
Classification Product Code
GXH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/27/2024
Decision Date
12/26/2024
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K243677
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