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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 K922140
Device Name ORTHODERM CONVERTIBLE II
Applicant
Bio Clinic Co.
4083 E. Airport Dr.
Ontario,  CA  91761
Applicant Contact GREG GODFREY
Correspondent
Bio Clinic Co.
4083 E. Airport Dr.
Ontario,  CA  91761
Correspondent Contact GREG GODFREY
Regulation Number890.5170
Classification Product Code
IOQ  
Date Received05/06/1992
Decision Date 05/27/1992
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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