The following data is part of a premarket notification filed by Strong Dental Inc. with the FDA for The Suad Device.
| Device ID | K023836 |
| 510k Number | K023836 |
| Device Name: | THE SUAD DEVICE |
| Classification | Device, Anti-snoring |
| Applicant | STRONG DENTAL INC. 21525 RIDGETOP CIRCLE SUITE 320 Sterling, VA 20166 |
| Contact | Clyde A Takeguchi |
| Correspondent | Clyde A Takeguchi STRONG DENTAL INC. 21525 RIDGETOP CIRCLE SUITE 320 Sterling, VA 20166 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-18 |
| Decision Date | 2003-07-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851826007144 | K023836 | 000 |
| 00851826007090 | K023836 | 000 |
| 00851826007083 | K023836 | 000 |