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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Manual, Specialized Obstetric-Gynecologic
510(k) Number K980717
Device Name UROMED SLING KIT
Applicant
Uromed Corp.
64 A St.
Needham,  MA  02194
Applicant Contact NANCY MACDONALD
Correspondent
Uromed Corp.
64 A St.
Needham,  MA  02194
Correspondent Contact NANCY MACDONALD
Regulation Number884.4530
Classification Product Code
KNA  
Date Received02/24/1998
Decision Date 05/22/1998
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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