Iovera System

Device, Surgical, Cryogenic

Pacira Pharmaceuticals Inc.

The following data is part of a premarket notification filed by Pacira Pharmaceuticals Inc. with the FDA for Iovera System.

Pre-market Notification Details

Device IDK211334
510k NumberK211334
Device Name:Iovera System
ClassificationDevice, Surgical, Cryogenic
Applicant Pacira Pharmaceuticals Inc. 46400 Fremont Blvd Fremont,  CA  94538
ContactKent Jones
CorrespondentKent Jones
Pacira Pharmaceuticals Inc. 46400 Fremont Blvd Fremont,  CA  94538
Product CodeGXH  
CFR Regulation Number882.4250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-03
Decision Date2021-09-10

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