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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 K952186
Device Name HSW GMBH HYSTEROSCOPES & ACCESSORIES
Applicant
HENKE-SASS WOLF, GMBH.
POSTFACH 2459
TUTTLINGEN,  DE 78507
Applicant Contact ARMIN LEKITSCH
Correspondent
HENKE-SASS WOLF, GMBH.
POSTFACH 2459
TUTTLINGEN,  DE 78507
Correspondent Contact ARMIN LEKITSCH
Regulation Number884.1690
Classification Product Code
HIH  
Date Received05/09/1995
Decision Date 02/06/1996
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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