Device Classification Name |
mesh, surgical, polymeric
|
510(k) Number |
K092032 |
Device Name |
BARD PERFIX LIGHT PLUG, MODELS 0117050, 0117060, 0117070, 0117080, 0117150, 0117160 |
Applicant |
DAVOL INC., SUB. C.R. BARD, INC. |
100 CROSSINGS BLVD |
WARWICK,
RI
02886
|
|
Applicant Contact |
GAIL DOW |
Correspondent |
DAVOL INC., SUB. C.R. BARD, INC. |
100 CROSSINGS BLVD |
WARWICK,
RI
02886
|
|
Correspondent Contact |
GAIL DOW |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 07/06/2009 |
Decision Date | 12/08/2009 |
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
|
Recalls |
CDRH Recalls
|
|
|