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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name laparoscope, gynecologic (and accessories)
510(k) Number K943598
Device Name FLEXIBLE FIBER OPTIC LAPAROSCOPES
Applicant
OPTIMED TECHNOLOGIES, INC.
1411 N. BATAVIA ST.
SUITE 114
ORANGE,  CA  92667
Applicant Contact RONALD J EHMSEN
Correspondent
OPTIMED TECHNOLOGIES, INC.
1411 N. BATAVIA ST.
SUITE 114
ORANGE,  CA  92667
Correspondent Contact RONALD J EHMSEN
Regulation Number884.1720
Classification Product Code
HET  
Date Received07/26/1994
Decision Date 10/18/1994
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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