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510(k) K093904

GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETER by Glenveigh Surgical, LLC — Product Code KNA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 2010
Date Received
December 22, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Manual, Specialized Obstetric-Gynecologic
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

Other clearances by Glenveigh Surgical, LLC

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