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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 K093904
Device Name GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETER
Applicant
GLENVEIGH SURGICAL, LLC
717 LAKEGLEN DRIVE
SUWANEE,  GA  30024
Applicant Contact PENNY NORTHCUTT
Correspondent
GLENVEIGH SURGICAL, LLC
717 LAKEGLEN DRIVE
SUWANEE,  GA  30024
Correspondent Contact PENNY NORTHCUTT
Regulation Number884.4530
Classification Product Code
KNA  
Date Received12/22/2009
Decision Date 04/14/2010
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
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