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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 K911551
Device Name SHOWER MINI RD-7 SANITARY WASHER
Applicant
Aiex USA , Ltd.
9650 Business Center Dr.
Suite 122
Rancho Cucamonga,  CA  91730
Applicant Contact BERNARD MCCLAY
Correspondent
Aiex USA , Ltd.
9650 Business Center Dr.
Suite 122
Rancho Cucamonga,  CA  91730
Correspondent Contact BERNARD MCCLAY
Regulation Number890.5100
Classification Product Code
ILJ  
Date Received04/08/1991
Decision Date 09/06/1991
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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