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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bath, Hydro-Massage
510(k) Number K810034
Device Name FOOT BATHS & HAND MASSAGERS
Applicant
Associated Mills, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Associated Mills, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.5100
Classification Product Code
ILJ  
Date Received01/06/1981
Decision Date 01/15/1981
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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