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510(k) K012546

OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEM by Sedecal USA, Inc. — Product Code KPR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 2001
Date Received
August 7, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Stationary
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type

Other clearances by Sedecal USA, Inc.

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  • K012663 — EASY MOVING MOBILE X-RAY UNIT (MODEL SM-HF) (August 31, 2001)

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