FDA 510(k) Application Details - K243677

Device Classification Name Device, Surgical, Cryogenic

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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
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Regulation Number 882.4250

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Classification Product Code GXH
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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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