The following data is part of a premarket notification filed by Sharn, Inc. with the FDA for Evac-tube.
| Device ID | K894032 |
| 510k Number | K894032 |
| Device Name: | EVAC-TUBE |
| Classification | Airway, Esophageal (obturator) |
| Applicant | SHARN, INC. 4801 GEORGE RD., #180 Tampa, FL 33634 |
| Contact | Bruce A Tomlinson |
| Correspondent | Bruce A Tomlinson SHARN, INC. 4801 GEORGE RD., #180 Tampa, FL 33634 |
| Product Code | CAO |
| CFR Regulation Number | 868.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-06 |
| Decision Date | 1989-08-31 |