The following data is part of a premarket notification filed by Medovations, Inc. with the FDA for Oxygen Connecting Tube.
Device ID | K830988 |
510k Number | K830988 |
Device Name: | OXYGEN CONNECTING TUBE |
Classification | Tubing, Pressure And Accessories |
Applicant | MEDOVATIONS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BYX |
CFR Regulation Number | 868.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-03-29 |
Decision Date | 1983-05-03 |