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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cannula, manipulator/injector, uterine
510(k) Number K935023
Device Name GODAT UTERINE MANIPULATOR INJECTOR
Applicant
IDEAS FOR MEDICINE, INC.
12167 49TH ST. NORTH
P.O. BOX 17327
CLEARWATER,  FL  34622
Applicant Contact LORNA K LINVILLE
Correspondent
IDEAS FOR MEDICINE, INC.
12167 49TH ST. NORTH
P.O. BOX 17327
CLEARWATER,  FL  34622
Correspondent Contact LORNA K LINVILLE
Regulation Number884.4530
Classification Product Code
LKF  
Date Received10/20/1993
Decision Date 01/04/1995
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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