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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 K922711
Device Name FLEXIBLE FIBER OPTIC GYNECOLOGIC ENDOSCOPE
Applicant
OPTIMED TECHNOLOGIES, INC.
2440 N. GLASSELL ST.
SUITE J
ORANGE,  CA  92665
Applicant Contact RONALD EHMSEN
Correspondent
OPTIMED TECHNOLOGIES, INC.
2440 N. GLASSELL ST.
SUITE J
ORANGE,  CA  92665
Correspondent Contact RONALD EHMSEN
Regulation Number884.1690
Classification Product Code
HIH  
Date Received06/05/1992
Decision Date 05/17/1994
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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