510(k) K030440
K030440 is an FDA 510(k) premarket notification submitted by Mark Abramson, D.D.S., Inc. for the device "OASYS-ORAL AIRWAY SYSTEM". The FDA issued a decision of Substantially Equivalent on Aug 26, 2003. The device falls under product code LRK (Device, Anti-Snoring), a Class II device regulated under 21 CFR 872.5570. Mark Abramson, D.D.S., Inc. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 26, 2003
- Date Received
- Feb 11, 2003
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Anti-Snoring
- Device Class
- Class II
- Regulation Number
- 872.5570
- Review Panel
- DE
- Submission Type
- 510(k)