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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 K933544
Device Name FUJINON VIDEO LAPORASCOPE
Applicant
FUJINON, INC.
399 PARK AVE.
NEW YORK,  NY  10022 -4689
Applicant Contact FREDERIC B ROSE
Correspondent
FUJINON, INC.
399 PARK AVE.
NEW YORK,  NY  10022 -4689
Correspondent Contact FREDERIC B ROSE
Regulation Number884.1690
Classification Product Code
HIH  
Date Received07/22/1993
Decision Date 04/27/1995
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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