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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 K780452
Device Name THERA-PAK
Applicant
Hydro-Med Products, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Hydro-Med Products, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number890.5720
Classification Product Code
ILO  
Date Received03/21/1978
Decision Date 06/21/1978
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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