The following data is part of a premarket notification filed by Manner Medical Products with the FDA for Tubing, Single Use Oxygen Supply.
Device ID | K760220 |
510k Number | K760220 |
Device Name: | TUBING, SINGLE USE OXYGEN SUPPLY |
Classification | Tubing, Pressure And Accessories |
Applicant | MANNER MEDICAL PRODUCTS 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 | 1976-07-12 |
Decision Date | 1976-08-03 |