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 |