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 |