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510(k) K913012

DIGITAL FLUORO STORE(DFS) W/NUMERICAL SUFFIXES by Eigen — Product Code JAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 1991
Date Received
July 8, 1991
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

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