The following data is part of a premarket notification filed by Mark Abramson, D.d.s., Inc with the FDA for Oasys-oral Airway System.
| Device ID | K030440 |
| 510k Number | K030440 |
| Device Name: | OASYS-ORAL AIRWAY SYSTEM |
| Classification | Device, Anti-snoring |
| Applicant | MARK ABRAMSON, D.D.S., INC 35 RENATO COURT Redwood City, CA 94061 |
| Contact | Mark Abramson |
| Correspondent | Mark Abramson MARK ABRAMSON, D.D.S., INC 35 RENATO COURT Redwood City, CA 94061 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-11 |
| Decision Date | 2003-08-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810002220029 | K030440 | 000 |
| 00810002220081 | K030440 | 000 |
| 00810002220074 | K030440 | 000 |
| 00810002220067 | K030440 | 000 |
| 00810002220050 | K030440 | 000 |
| 00810002220043 | K030440 | 000 |