Genzyme Surgical Product (Genzyme Biosurgery) · Class II · Cleared Jun 12, 2000
| K-number | K001434 |
| Device name | 'COTTONY' II DACRON, SILKY II POLYDEK & TEVDEK II POLYESTER NONABSORBABLE SURGICAL SUTURE |
| Applicant | Genzyme Surgical Product (Genzyme Biosurgery) |
| Product code | GAT |
| Device class | Class II |
| Decision date | Jun 12, 2000 |
| Decision | Substantially Equivalent for Some Indications |
| Regulation | 878.5000 |
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