The following data is part of a premarket notification filed by Nebl, Inc. with the FDA for Restore (aka Re/stor).
| Device ID | K983164 |
| 510k Number | K983164 |
| Device Name: | RESTORE (AKA RE/STOR) |
| Classification | External Urethral Occluder, Urinary Incontinence-control, Female |
| Applicant | NEBL, INC. 44 TERRACE DR. Worchester, MA 01609 |
| Contact | Jeffrey A Dann |
| Correspondent | Jeffrey A Dann NEBL, INC. 44 TERRACE DR. Worchester, MA 01609 |
| Product Code | MNG |
| CFR Regulation Number | 876.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-10 |
| Decision Date | 1999-03-05 |
| Summary: | summary |