The following data is part of a premarket notification filed by Parker Medical Assoc. with the FDA for Parker Flex-tip Tracheal Tube.
| Device ID | K984528 |
| 510k Number | K984528 |
| Device Name: | PARKER FLEX-TIP TRACHEAL TUBE |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | PARKER MEDICAL ASSOC. 109 INVERNESS DRIVE EAST, SUITE J Englewood, CO 80112 -5105 |
| Contact | Jeffrey D Parker |
| Correspondent | Jeffrey D Parker PARKER MEDICAL ASSOC. 109 INVERNESS DRIVE EAST, SUITE J Englewood, CO 80112 -5105 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-21 |
| Decision Date | 1999-07-15 |
| Summary: | summary |