The following data is part of a premarket notification filed by Genzyme Surgical Product (genzyme Biosurgery) with the FDA for 'cottony' Ii Dacron, Silky Ii Polydek & Tevdek Ii Polyester Nonabsorbable Surgical Suture.
| Device ID | K001434 |
| 510k Number | K001434 |
| Device Name: | 'COTTONY' II DACRON, SILKY II POLYDEK & TEVDEK II POLYESTER NONABSORBABLE SURGICAL SUTURE |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY) 600 AIRPORT RD. Fall River, MA 02720 -4740 |
| Contact | Mary E Gray |
| Correspondent | Mary E Gray GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY) 600 AIRPORT RD. Fall River, MA 02720 -4740 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-08 |
| Decision Date | 2000-06-12 |