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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 K012935
Device Name THECURVE, ITEM 507
Applicant
SELECT MEDICAL SYSTEMS, INC.
P.O. BOX 966
WILLISTON,  VT  05495 -0966
Applicant Contact MONIQUE GIRARD
Correspondent
SELECT MEDICAL SYSTEMS, INC.
P.O. BOX 966
WILLISTON,  VT  05495 -0966
Correspondent Contact MONIQUE GIRARD
Regulation Number884.5250
Classification Product Code
MFD  
Date Received08/31/2001
Decision Date 10/11/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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