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510(k) K050701

THIGH AND FOOT POSITIONER, SUPRONE PLUS, MODEL RT-6010 by Bionix Development Corp. — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 2005
Date Received
March 18, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Accelerator, Linear, Medical
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type

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