The following data is part of a premarket notification filed by Venture Therapeutics, Inc. with the FDA for Oc-flex Flexible Intraoral Cannula.
| Device ID | K161250 |
| 510k Number | K161250 |
| Device Name: | OC-FLEX Flexible IntraOral Cannula |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | Venture Therapeutics, Inc. 6525 Doubletree Avenue Columbus, OH 43229 |
| Contact | Marilyn A. Friedly |
| Correspondent | Marilyn A. Friedly Venture Therapeutics, Inc. 6525 Doubletree Avenue Columbus, OH 43229 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-03 |
| Decision Date | 2017-03-17 |
| Summary: | summary |