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 |