The following data is part of a premarket notification filed by William Cook Europe Aps with the FDA for Frova Intubating Introducer.
| Device ID | K161813 |
| 510k Number | K161813 |
| Device Name: | Frova Intubating Introducer |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | WILLIAM COOK EUROPE APS SANDET 6 Bjaeverskov, DK 4632 |
| Contact | Henriette Stordal Christiansen |
| Correspondent | Henriette Stordal Christiansen WILLIAM COOK EUROPE APS SANDET 6 Bjaeverskov, DK 4632 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-01 |
| Decision Date | 2017-05-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00827002535176 | K161813 | 000 |
| 10827002483030 | K161813 | 000 |
| 00827002236462 | K161813 | 000 |
| 00827002236455 | K161813 | 000 |