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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 K913729
Device Name POLAR PUMP, MODEL 500
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 Received08/20/1991
Decision Date 10/18/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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