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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 K982630
Device Name MEDWORKS VISUALIZATION INSEMINATION CATHETER
Applicant
Medworks Corp.
50 Brewster St.
Pawtucket,  RI  02860
Applicant Contact PAMELA PAPINEAU
Correspondent
Medworks Corp.
50 Brewster St.
Pawtucket,  RI  02860
Correspondent Contact PAMELA PAPINEAU
Regulation Number884.5250
Classification Product Code
MFD  
Date Received07/28/1998
Decision Date 01/14/1999
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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