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 |