The following data is part of a premarket notification filed by Kevtek Medical Products, Inc. with the FDA for Kevtek Laser-stop Endotracheal Tube Laser-stop.
| Device ID | K902193 |
| 510k Number | K902193 |
| Device Name: | KEVTEK LASER-STOP ENDOTRACHEAL TUBE LASER-STOP |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | KEVTEK MEDICAL PRODUCTS, INC. P.O. BOX 580644 Houston, TX 77258 |
| Contact | L Weinberg |
| Correspondent | L Weinberg KEVTEK MEDICAL PRODUCTS, INC. P.O. BOX 580644 Houston, TX 77258 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-16 |
| Decision Date | 1991-03-15 |