Device Classification Name |
intrauterine tamponade balloon
|
510(k) Number |
K091958 |
Device Name |
BELFORT-DILDY OBSTETRIC TAMPONADE SYSTEM |
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 Number | 884.4530
|
Classification Product Code |
|
Date Received | 07/01/2009 |
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
|
|
|