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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K050701
Device Name THIGH AND FOOT POSITIONER, SUPRONE PLUS, MODEL RT-6010
Applicant
Bionix Development Corp.
5154 Enterprise Blvd.
Toledo,  OH  43612
Applicant Contact JAMES HUTTNER
Correspondent
Entela, Inc.
3033 Madison Ave., SE
Grand Rapids,  MI  49548
Correspondent Contact NED DEVINE
Regulation Number892.5050
Classification Product Code
IYE  
Date Received03/18/2005
Decision Date 04/01/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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