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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 K892390
Device Name FLEXIBLE IMMERSIBLE HYSTEROSCOPE
Applicant
SCHOTT FIBER OPTICS, INC.
122 CHARLTON ST.
SOUTHBRIDGE,  MA  01550
Applicant Contact RICHARD F TAYLOR
Correspondent
SCHOTT FIBER OPTICS, INC.
122 CHARLTON ST.
SOUTHBRIDGE,  MA  01550
Correspondent Contact RICHARD F TAYLOR
Regulation Number884.1690
Classification Product Code
HIH  
Date Received04/07/1989
Decision Date 02/02/1990
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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