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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 K844064
Device Name MEDO BUBBLE BATH MA-80, 400, 600 & 700
Applicant
Medo U.S.A., Inc.
P.O. Box 129
Wood Dale,  IL  60191
Applicant Contact HIROSHI OKAZAKI
Correspondent
Medo U.S.A., Inc.
P.O. Box 129
Wood Dale,  IL  60191
Correspondent Contact HIROSHI OKAZAKI
Regulation Number890.5100
Classification Product Code
ILJ  
Date Received10/18/1984
Decision Date 01/23/1985
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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