The following data is part of a premarket notification filed by Vitaid, Ltd. with the FDA for Laser Shielding Tube.
| Device ID | K894669 |
| 510k Number | K894669 |
| Device Name: | LASER SHIELDING TUBE |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | VITAID, LTD. 147 OLD ORCHARD GROVE TORONTO, ONTARIO, CANADA M5m 2e1, CA |
| Contact | William G Stewart |
| Correspondent | William G Stewart VITAID, LTD. 147 OLD ORCHARD GROVE TORONTO, ONTARIO, CANADA M5m 2e1, CA |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-24 |
| Decision Date | 1989-10-13 |