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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name pack, hot or cold, water circulating
510(k) Number K920581
Device Name POLAR PAD (STERILE)
Applicant
BREG, INC.
344 22ND ST.
COSTA MESA,  CA  92627
Applicant Contact NANCY A WILLCOX
Correspondent
BREG, INC.
344 22ND ST.
COSTA MESA,  CA  92627
Correspondent Contact NANCY A WILLCOX
Regulation Number890.5720
Classification Product Code
ILO  
Date Received02/10/1992
Decision Date 03/20/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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