Device Classification Name |
mesh, surgical, polymeric
|
510(k) Number |
K991637 |
Device Name |
BARD SPERMA-TEX PRESHAPED MESH (2.4X5.6), MODEL 0114700 |
Applicant |
DAVOL, INC., SUB. C.R. BARD, INC. |
100 SOCKANOSSETT CROSSROAD |
CRANSTON,
RI
02920
|
|
Applicant Contact |
RINI GEORGEKUTTY |
Correspondent |
DAVOL, INC., SUB. C.R. BARD, INC. |
100 SOCKANOSSETT CROSSROAD |
CRANSTON,
RI
02920
|
|
Correspondent Contact |
RINI GEORGEKUTTY |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 05/12/1999 |
Decision Date | 06/22/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|