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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 K861218
Device Name AQUA ARK, IMMERSION HYDROBATH
Applicant
Aqua Ark, Inc.
C/O Commonwealth Med Corp Amer
751 N. 7th St.
Allentown,  PA  18102
Applicant Contact THEODORE BERLIN
Correspondent
Aqua Ark, Inc.
C/O Commonwealth Med Corp Amer
751 N. 7th St.
Allentown,  PA  18102
Correspondent Contact THEODORE BERLIN
Regulation Number890.5100
Classification Product Code
ILJ  
Date Received03/31/1986
Decision Date 04/18/1986
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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