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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Bed, Flotation Therapy, Powered
510(k) Number K771264
Device Name FLOTATION THERAPY BED
Applicant
Aquarius Medical Services
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Aquarius Medical Services
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.5170
Classification Product Code
IOQ  
Date Received07/11/1977
Decision Date 08/02/1977
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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