Device Classification Name |
Mesh, Surgical, Polymeric
|
510(k) Number |
K922916 |
FOIA Releasable 510(k) |
K922916
|
Device Name |
BARD MARLEX MESH DART |
Applicant |
C.R. BARD, INC. |
1200 TECHNOLOGY PARK DR. |
P.O. BOX 7025 |
BILLERICA,
MA
01821
|
|
Applicant Contact |
CRAIG M AUDET |
Correspondent |
C.R. BARD, INC. |
1200 TECHNOLOGY PARK DR. |
P.O. BOX 7025 |
BILLERICA,
MA
01821
|
|
Correspondent Contact |
CRAIG M AUDET |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 06/17/1992 |
Decision Date | 08/24/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|