The following data is part of a premarket notification filed by Invotec International, Inc. with the FDA for Tracheostomy T-tube.
| Device ID | K930114 |
| 510k Number | K930114 |
| Device Name: | TRACHEOSTOMY T-TUBE |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | INVOTEC INTERNATIONAL, INC. 11221- 5 ST. JOHNS INDUSTRIAL PARKWAY Jacksonville, FL 32216 |
| Contact | Jeffrey L Hull |
| Correspondent | Jeffrey L Hull INVOTEC INTERNATIONAL, INC. 11221- 5 ST. JOHNS INDUSTRIAL PARKWAY Jacksonville, FL 32216 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-11 |
| Decision Date | 1993-03-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00818501020140 | K930114 | 000 |
| 00818501020065 | K930114 | 000 |
| 00818501020072 | K930114 | 000 |
| 00818501020089 | K930114 | 000 |
| 00818501020096 | K930114 | 000 |
| 00818501020102 | K930114 | 000 |
| 00818501020119 | K930114 | 000 |
| 00818501020126 | K930114 | 000 |
| 00818501020133 | K930114 | 000 |
| 00818501020058 | K930114 | 000 |