The following data is part of a premarket notification filed by Trebay Medical Corp. with the FDA for At2 & Doyle Style (c-flex) Vent Tubes.
| Device ID | K954795 |
| 510k Number | K954795 |
| Device Name: | AT2 & DOYLE STYLE (C-FLEX) VENT TUBES |
| Classification | Tube, Tympanostomy |
| Applicant | TREBAY MEDICAL CORP. 4911 CREEKSIDE DR. Clearwater, FL 34620 |
| Contact | Dan H Treace |
| Correspondent | Dan H Treace TREBAY MEDICAL CORP. 4911 CREEKSIDE DR. Clearwater, FL 34620 |
| Product Code | ETD |
| CFR Regulation Number | 874.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-18 |
| Decision Date | 1995-11-15 |