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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 K926456
Device Name MICROAIR TURN-Q
Applicant
Gsi Development Co.
2 Commerce Dr.
Carmel,  NY  10512
Applicant Contact OLIVER H BODINE
Correspondent
Gsi Development Co.
2 Commerce Dr.
Carmel,  NY  10512
Correspondent Contact OLIVER H BODINE
Regulation Number890.5170
Classification Product Code
IOQ  
Date Received12/24/1992
Decision Date 03/24/1993
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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