The following data is part of a premarket notification filed by Genzyme Corporation with the FDA for Sepragel Ent Bioresorbable Packing/stent.
| Device ID | K043035 |
| 510k Number | K043035 |
| Device Name: | SEPRAGEL ENT BIORESORBABLE PACKING/STENT |
| Classification | Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) |
| Applicant | GENZYME CORPORATION 55 CAMBRIDGE PARKWAY Cambridge, MA 02142 |
| Contact | Barbara Pizza |
| Correspondent | Barbara Pizza GENZYME CORPORATION 55 CAMBRIDGE PARKWAY Cambridge, MA 02142 |
| Product Code | KHJ |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-03 |
| Decision Date | 2005-07-11 |
| Summary: | summary |