The following data is part of a premarket notification filed by Genzyme Biosurgery with the FDA for Monodek Synthetic Absorbable Surgical Suture.
| Device ID | K030212 |
| 510k Number | K030212 |
| Device Name: | MONODEK SYNTHETIC ABSORBABLE SURGICAL SUTURE |
| Classification | Suture, Surgical, Absorbable, Polydioxanone |
| Applicant | GENZYME BIOSURGERY 600 AIRPORT RD. Fall River, MA 02720 -4740 |
| Contact | Steve Page |
| Correspondent | Steve Page GENZYME BIOSURGERY 600 AIRPORT RD. Fall River, MA 02720 -4740 |
| Product Code | NEW |
| CFR Regulation Number | 878.4840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-21 |
| Decision Date | 2003-03-27 |
| Summary: | summary |