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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hysteroscope (And Accessories)
510(k) Number K950055
Device Name A4722 OLYMPUS OPTICAL OBTURATOR
Applicant
OLYMPUS AMERICA, INC.
4 NEVADA DR.
LAKE SUCCESS,  NY  11042 -1179
Applicant Contact BARRY E SANDS
Correspondent
OLYMPUS AMERICA, INC.
4 NEVADA DR.
LAKE SUCCESS,  NY  11042 -1179
Correspondent Contact BARRY E SANDS
Regulation Number884.1690
Classification Product Code
HIH  
Date Received01/06/1995
Decision Date 02/21/1995
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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