The following data is part of a premarket notification filed by Concord/portex with the FDA for D.i.c. Tracheostomy Tubes & Laryngectomy Tubes.
| Device ID | K903730 |
| 510k Number | K903730 |
| Device Name: | D.I.C. TRACHEOSTOMY TUBES & LARYNGECTOMY TUBES |
| Classification | Tube, Tracheostomy (w/wo Connector) |
| Applicant | CONCORD/PORTEX 15 KITT ST. Keene, NH 03431 |
| Contact | Robert Wheeler |
| Correspondent | Robert Wheeler CONCORD/PORTEX 15 KITT ST. Keene, NH 03431 |
| Product Code | BTO |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-16 |
| Decision Date | 1990-09-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10351688041166 | K903730 | 000 |
| 30351688005896 | K903730 | 000 |
| 10351688009586 | K903730 | 000 |
| 10351688012883 | K903730 | 000 |
| 10351688017949 | K903730 | 000 |
| 10351688018670 | K903730 | 000 |
| 10351688018809 | K903730 | 000 |
| 30351688018858 | K903730 | 000 |
| 10351688033239 | K903730 | 000 |
| 10351688034045 | K903730 | 000 |
| 10351688036674 | K903730 | 000 |
| 30351688036715 | K903730 | 000 |
| 10351688037176 | K903730 | 000 |
| 30351688041122 | K903730 | 000 |
| 30351688041139 | K903730 | 000 |
| 50351688041140 | K903730 | 000 |
| 30351688041153 | K903730 | 000 |
| 10351688003782 | K903730 | 000 |