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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 K925195
Device Name MALIBU BATHING SYSTEM
Applicant
Medi-Man Rehabilitation Products, Inc.
5630 Tomken Rd.
Mississauga, Ontario,
Canada, L4w 1p4,  CA
Applicant Contact JANE BELROSE
Correspondent
Medi-Man Rehabilitation Products, Inc.
5630 Tomken Rd.
Mississauga, Ontario,
Canada, L4w 1p4,  CA
Correspondent Contact JANE BELROSE
Regulation Number890.5100
Classification Product Code
ILJ  
Date Received10/15/1992
Decision Date 10/17/1994
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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