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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 K883308
Device Name PARKER BATHING SYSTEM
Applicant
Mid-Canada Medical
5630 Tomken Rd.
Mississauga, Ontario,  CA L4W 1P4
Applicant Contact LINDA STRONG
Correspondent
Mid-Canada Medical
5630 Tomken Rd.
Mississauga, Ontario,  CA L4W 1P4
Correspondent Contact LINDA STRONG
Regulation Number890.5100
Classification Product Code
ILJ  
Date Received08/05/1988
Decision Date 09/22/1988
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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