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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, Disposable
510(k) Number K873364
Device Name HYPERTHERM TECHNOLOGIES' HEAT COMPRESS
Applicant
Hypertherm Technologies, Inc.
9424 Sheridan Rd.
Kenosha,  WI  53140
Applicant Contact CARL W PODELLA
Correspondent
Hypertherm Technologies, Inc.
9424 Sheridan Rd.
Kenosha,  WI  53140
Correspondent Contact CARL W PODELLA
Regulation Number890.5710
Classification Product Code
IMD  
Date Received08/21/1987
Decision Date 11/17/1987
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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