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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 K863047
Device Name FLEXICAIR
Applicant
SSI MEDICAL SERVICES, INC.
BURDITT RADZIUS CHARTERED
333 W.WACKER DR.SUITE 2600
CHICAGO,  IL  60606
Applicant Contact J. R RADZIUS
Correspondent
SSI MEDICAL SERVICES, INC.
BURDITT RADZIUS CHARTERED
333 W.WACKER DR.SUITE 2600
CHICAGO,  IL  60606
Correspondent Contact J. R RADZIUS
Regulation Number890.5170
Classification Product Code
IOQ  
Date Received08/12/1986
Decision Date 09/05/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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