OLYMPUS LTF-S190-10, OLUMPUS OTV-S190, OLYMPUS CLV-S190


Device Classification Name

laparoscope, gynecologic (and accessories)

510(k) Number K111425
Device Name OLYMPUS LTF-S190-10, OLUMPUS OTV-S190, OLYMPUS CLV-S190
Applicant
OLYMPUS MEDICAL SYSTEMS CORP.
3500 corporate parkway
p.o. box 610
center valley, 
PA 
18034 -0610

Applicant Contact sheri musgnung
Correspondent
OLYMPUS MEDICAL SYSTEMS CORP.
3500 corporate parkway
p.o. box 610
center valley, 
PA 
18034 -0610

Correspodent Contact sheri musgnung
Regulation Number 884.1720
Classification Product Code
HET  
Subsequent Product Codes
EOB   EOQ   FGB   GCJ   NWB  
Date Received 05/23/2011
Decision Date 04/20/2012
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