The following data is part of a premarket notification filed by Vitaid, Ltd. with the FDA for Pediatric Cuffed And Uncuffed Et Tubes; Standard Cuffed And Uncuffed Et Tubes.
| Device ID | K050803 |
| 510k Number | K050803 |
| Device Name: | PEDIATRIC CUFFED AND UNCUFFED ET TUBES; STANDARD CUFFED AND UNCUFFED ET TUBES |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | VITAID, LTD. 6329 W. WATERVIEW CT. Mccordsville, IN 46055 -9501 |
| Contact | Paul E Dryden |
| Correspondent | Paul E Dryden VITAID, LTD. 6329 W. WATERVIEW CT. Mccordsville, IN 46055 -9501 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-30 |
| Decision Date | 2005-06-30 |
| Summary: | summary |