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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, Gynecologic (And Accessories)
510(k) Number K123365
Device Name OLYMPUS LTF-190-10-3D, MAJ-Y0154, OLYMPUS CV-190
Applicant
Olympus Medical Systems Corp.
3500 Corporate Pkwy., P.O. Box 610
Center Valley,  PA  18034 -0610
Applicant Contact SHERI L MUSGNUNG
Correspondent
Olympus Medical Systems Corp.
3500 Corporate Pkwy., P.O. Box 610
Center Valley,  PA  18034 -0610
Correspondent Contact SHERI L MUSGNUNG
Regulation Number884.1720
Classification Product Code
HET  
Subsequent Product Codes
FGB   GCJ   NWB  
Date Received10/31/2012
Decision Date 03/01/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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