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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 K902563
Device Name MONOSCOPY(TM) BRAND, TROCAR REDUCER SET
Applicant
DEXIDE, INC.
P.O. BOX 185789
FT. WORTH,  TX  76181
Applicant Contact KEITH JUNG
Correspondent
DEXIDE, INC.
P.O. BOX 185789
FT. WORTH,  TX  76181
Correspondent Contact KEITH JUNG
Regulation Number884.1720
Classification Product Code
HET  
Date Received06/11/1990
Decision Date 09/04/1990
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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