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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 K992779
Device Name A-2000 BATHING SYSTEMS; HYDROSONIC BATHIN SYSTEM
Applicant
Medi-Man Rehabilitation Products, Inc.
6200 Tomken Rd.
Mississauga, Ontario,  CA L5T 1X7
Applicant Contact JOHN T MOGENSEN
Correspondent
Medi-Man Rehabilitation Products, Inc.
6200 Tomken Rd.
Mississauga, Ontario,  CA L5T 1X7
Correspondent Contact JOHN T MOGENSEN
Regulation Number890.5100
Classification Product Code
ILJ  
Date Received08/18/1999
Decision Date 01/13/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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