Device Classification Name |
Suture, Absorbable, Synthetic, Polyglycolic Acid
|
510(k) Number |
K022269 |
Device Name |
COATED VICRYL* (POLYGLACTIN 910) SUTURE |
Applicant |
ETHICON, INC. |
P.O BOX 151, ROUTE 22 WEST |
SOMERVILLE,
NJ
08876
|
|
Applicant Contact |
LEA ANN CONWAY |
Correspondent |
ETHICON, INC. |
P.O BOX 151, ROUTE 22 WEST |
SOMERVILLE,
NJ
08876
|
|
Correspondent Contact |
LEA ANN CONWAY |
Regulation Number | 878.4493
|
Classification Product Code |
|
Date Received | 07/15/2002 |
Decision Date | 09/13/2002 |
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
|
|
|