The following data is part of a premarket notification filed by Nellcor Puritan Bennett, Inc. with the FDA for Shiley Flextra Tracheostomy Tube.
| Device ID | K030787 |
| 510k Number | K030787 |
| Device Name: | SHILEY FLEXTRA TRACHEOSTOMY TUBE |
| Classification | Tube Tracheostomy And Tube Cuff |
| Applicant | NELLCOR PURITAN BENNETT, INC. 4280 HACIENDA DR. Pleasanton, CA 94588 -2719 |
| Contact | Gina To |
| Correspondent | Gina To NELLCOR PURITAN BENNETT, INC. 4280 HACIENDA DR. Pleasanton, CA 94588 -2719 |
| Product Code | JOH |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-12 |
| Decision Date | 2003-11-14 |
| Summary: | summary |