The following data is part of a premarket notification filed by Steven B. Lamberg, Dds with the FDA for Lambergsleepwell- Smartrusion (lsw-s).
| Device ID | K101709 |
| 510k Number | K101709 |
| Device Name: | LAMBERGSLEEPWELL- SMARTRUSION (LSW-S) |
| Classification | Device, Anti-snoring |
| Applicant | STEVEN B. LAMBERG, DDS 800 E. LEIGH STREET SUITE 206-5 Richmond, VA 23219 |
| Contact | Emily B Rossiter |
| Correspondent | Emily B Rossiter STEVEN B. LAMBERG, DDS 800 E. LEIGH STREET SUITE 206-5 Richmond, VA 23219 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-17 |
| Decision Date | 2010-08-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D85463603L1 | K101709 | 000 |
| D85463603NS1 | K101709 | 000 |
| D85463603PMTS1 | K101709 | 000 |
| D85463603WS1 | K101709 | 000 |
| D85463260S1 | K101709 | 000 |
| D85463603AACS1 | K101709 | 000 |
| D85463603AAO2S1 | K101709 | 000 |
| D85463603AAS1 | K101709 | 000 |
| D85463603ACO2S1 | K101709 | 000 |
| D85463603ALCS1 | K101709 | 000 |
| D85463603AO2S1 | K101709 | 000 |
| D85463603AS1 | K101709 | 000 |
| D85463603LS1 | K101709 | 000 |