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510(k) K884578

POLARIX 2 AND POLARIX 2E by Dyna-Med — Product Code JAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 1989
Date Received
November 1, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Fluoroscopic, Image-Intensified
Device Class
Class II
Regulation Number
892.1650
Review Panel
RA
Submission Type

Other clearances by Dyna-Med

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