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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 K243677
Device Name iovera° System
Applicant
Pacira Biosciences, Inc.
10410 Science Center Dr., Bldg. A
San Diego,  CA  92121
Applicant Contact Niloufa Insanally
Correspondent
Pacira Biosciences, Inc.
10410 Science Center Dr., Bldg. A
San Diego,  CA  92121
Correspondent Contact Niloufa Insanally
Regulation Number882.4250
Classification Product Code
GXH  
Subsequent Product Code
ETN  
Date Received11/27/2024
Decision Date 12/26/2024
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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