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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Surgical, Cryogenic
510(k) Number K211334
Device Name Iovera System
Applicant
Pacira Pharmaceuticals, Inc.
46400 Fremont Blvd.
Fremont,  CA  94538
Applicant Contact Kent Jones
Correspondent
Pacira Pharmaceuticals, Inc.
46400 Fremont Blvd.
Fremont,  CA  94538
Correspondent Contact Kent Jones
Regulation Number882.4250
Classification Product Code
GXH  
Date Received05/03/2021
Decision Date 09/10/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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