POLAR PADS

Pack, Hot Or Cold, Water Circulating

BREG, INC.

The following data is part of a premarket notification filed by Breg, Inc. with the FDA for Polar Pads.

Pre-market Notification Details

Device IDK914434
510k NumberK914434
Device Name:POLAR PADS
ClassificationPack, Hot Or Cold, Water Circulating
Applicant BREG, INC. 344 22ND ST. Costa Mesa,  CA  92627
ContactNancy A Willcox
CorrespondentNancy A Willcox
BREG, INC. 344 22ND ST. Costa Mesa,  CA  92627
Product CodeILO  
CFR Regulation Number890.5720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-10-04
Decision Date1991-10-24

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