Device Classification Name |
mesh, surgical, synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed
|
510(k) Number |
K063712 |
FOIA Releasable 510(k) |
K063712
|
Device Name |
AVAULTA SUPPORT SYSTEM/AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM |
Applicant |
C.R. BARD, INC. |
13183 HARLAND DRIVE |
COVINGTON,
GA
30014 -6421
|
|
Applicant Contact |
JOHN C KNORPP |
Correspondent |
C.R. BARD, INC. |
13183 HARLAND DRIVE |
COVINGTON,
GA
30014 -6421
|
|
Correspondent Contact |
JOHN C KNORPP |
Regulation Number | 884.5980
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/14/2006 |
Decision Date | 03/12/2007 |
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
|
|
|