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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cannula, intrauterine insemination
510(k) Number K954099
Device Name SELECT IUI
Applicant
SELECT MEDICAL SYSTEMS, INC.
2 WINTERSPORT LN.
WILLISTON,  VT  05495
Applicant Contact MONIQUE GIRARD
Correspondent
SELECT MEDICAL SYSTEMS, INC.
2 WINTERSPORT LN.
WILLISTON,  VT  05495
Correspondent Contact MONIQUE GIRARD
Regulation Number884.5250
Classification Product Code
MFD  
Date Received08/31/1995
Decision Date 11/22/1995
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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