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510(k) K123365

OLYMPUS LTF-190-10-3D, MAJ-Y0154, OLYMPUS CV-190 by Olympus Medical Systems Corp. — Product Code HET

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 2013
Date Received
October 31, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laparoscope, Gynecologic (And Accessories)
Device Class
Class II
Regulation Number
884.1720
Review Panel
OB
Submission Type

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