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510(k) K132289

GEMSS MEDICAL SYSTEMS SURGICAL MOBILE FLUOROSCOPIC X-RAY SYSTEM by Gemss Medical Systems Co., Ltd. — Product Code JAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 2014
Date Received
July 23, 2013
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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