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510(k) K111425

OLYMPUS LTF-S190-10, OLUMPUS OTV-S190, OLYMPUS CLV-S190 by Olympus Medical Systems Corp. — Product Code HET

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 2012
Date Received
May 23, 2011
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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