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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 K790480
Device Name TULANE HEAT-PACK
Applicant
TULANE
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
TULANE
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number890.5710
Classification Product Code
IMD  
Date Received03/08/1979
Decision Date 04/03/1979
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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