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510(k) K004037

X-RAY SYSTEM XR-MX by Karl Storz Endoscopy — Product Code JAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 2001
Date Received
December 28, 2000
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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  • K011841 — KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR (September 10, 2001)
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