The following data is part of a premarket notification filed by Genzyme Corp. with the FDA for Cottony Ii, Silky Ii Polydek & Tevdek Ii Polyester Suture.
Device ID | K021019 |
510k Number | K021019 |
Device Name: | COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE |
Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
Applicant | GENZYME CORP. 600 AIRPORT RD. Fall River, MA 02720 -4740 |
Contact | Mary Gray |
Correspondent | Mary Gray GENZYME CORP. 600 AIRPORT RD. Fall River, MA 02720 -4740 |
Product Code | GAT |
CFR Regulation Number | 878.5000 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-03-29 |
Decision Date | 2002-06-18 |
Summary: | summary |