The following data is part of a premarket notification filed by Influence, Inc. with the FDA for Sleep-in Bone Screw System.
| Device ID | K972023 |
| 510k Number | K972023 |
| Device Name: | SLEEP-IN BONE SCREW SYSTEM |
| Classification | Device, Anti-snoring |
| Applicant | INFLUENCE, INC. 601 MONTGOMERY ST., SUITE 845 San Francisco, CA 94111 |
| Contact | Peter A Bick |
| Correspondent | Peter A Bick INFLUENCE, INC. 601 MONTGOMERY ST., SUITE 845 San Francisco, CA 94111 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-02 |
| Decision Date | 1997-08-25 |
| Summary: | summary |