The following data is part of a premarket notification filed by Ascentia Health Incorporated with the FDA for Clayton Intra-aural Device (cid).
| Device ID | K091880 |
| 510k Number | K091880 |
| Device Name: | CLAYTON INTRA-AURAL DEVICE (CID) |
| Classification | Mouthguard, Prescription |
| Applicant | ASCENTIA HEALTH INCORPORATED 8473 RIPPLED CREEK COURT Springfield, VA 22153 |
| Contact | Roger Wixtrom |
| Correspondent | Roger Wixtrom ASCENTIA HEALTH INCORPORATED 8473 RIPPLED CREEK COURT Springfield, VA 22153 |
| Product Code | MQC |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-24 |
| Decision Date | 2010-02-24 |
| Summary: | summary |