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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Kit, Nephroscope
510(k) Number K922826
Device Name FLEXIBLE FIBER OPTIC ENDOSCOPE
Applicant
OPTIMED TECHNOLOGIES, INC.
2440 N. GLASSELL ST.
SUITE J
ORANGE,  CA  92665
Applicant Contact RONALD J EHMSEN
Correspondent
OPTIMED TECHNOLOGIES, INC.
2440 N. GLASSELL ST.
SUITE J
ORANGE,  CA  92665
Correspondent Contact RONALD J EHMSEN
Regulation Number876.1500
Classification Product Code
FGA  
Date Received06/11/1992
Decision Date 02/19/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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