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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pack, Heat, Moist
510(k) Number K841698
Device Name HEAT PACK
Applicant
Maddak, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Maddak, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number890.5730
Classification Product Code
IMA  
Date Received04/23/1984
Decision Date 05/10/1984
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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