The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Merogel Injectable Bioresorbable Stent.
| Device ID | K070886 |
| 510k Number | K070886 |
| Device Name: | MEROGEL INJECTABLE BIORESORBABLE STENT |
| Classification | Polymer, Ear, Nose And Throat, Synthetic, Absorbable |
| Applicant | MEDTRONIC INC. 6743 SOUTHPOINT DRIVE NORTH Jacksonville, FL 32259 |
| Contact | Jayme Wilson |
| Correspondent | Jayme Wilson MEDTRONIC INC. 6743 SOUTHPOINT DRIVE NORTH Jacksonville, FL 32259 |
| Product Code | NHB |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-30 |
| Decision Date | 2007-04-26 |
| Summary: | summary |