Device Classification Name |
suture, nonabsorbable, synthetic, polyethylene
|
510(k) Number |
K021019 |
Device Name |
COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE |
Applicant |
GENZYME CORP. |
600 AIRPORT RD. |
FALL RIVER,
MA
02720 -4740
|
|
Applicant Contact |
MARY GRAY |
Correspondent |
GENZYME CORP. |
600 AIRPORT RD. |
FALL RIVER,
MA
02720 -4740
|
|
Correspondent Contact |
MARY GRAY |
Regulation Number | 878.5000
|
Classification Product Code |
|
Date Received | 03/29/2002 |
Decision Date | 06/18/2002 |
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
|