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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intrauterine Tamponade Balloon
510(k) Number K091958
Device Name BELFORT-DILDY OBSTETRIC TAMPONADE SYSTEM
Applicant
Glenveigh Surgical, LLC
717 Lakeglen Dr.
Swanee,  GA  30024
Applicant Contact PENNY NORTHCUTT
Correspondent
Glenveigh Surgical, LLC
717 Lakeglen Dr.
Swanee,  GA  30024
Correspondent Contact PENNY NORTHCUTT
Regulation Number884.4530
Classification Product Code
OQY  
Date Received07/01/2009
Decision Date 04/30/2010
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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