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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 K905126
Device Name COMFORT-AIRE
Applicant
Advanced Air Dynamics, Inc.
27335 SW 166 Ave.
Homestead,  FL  33031
Applicant Contact ANTHONY G DACOSTA
Correspondent
Advanced Air Dynamics, Inc.
27335 SW 166 Ave.
Homestead,  FL  33031
Correspondent Contact ANTHONY G DACOSTA
Regulation Number890.5170
Classification Product Code
IOQ  
Date Received11/14/1990
Decision Date 12/19/1990
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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