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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 K942838
Device Name OLYMPUS SUPERVIEW LAPAROSCOPE FOR OB/GYN
Applicant
OLYMPUS AMERICA, INC.
4 NEVADA DR.
LAKE SUCCESS,  NY  11042 -1179
Applicant Contact BARRY SANDS
Correspondent
OLYMPUS AMERICA, INC.
4 NEVADA DR.
LAKE SUCCESS,  NY  11042 -1179
Correspondent Contact BARRY SANDS
Regulation Number884.1720
Classification Product Code
HET  
Date Received06/15/1994
Decision Date 10/31/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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