The following data is part of a premarket notification filed by Inspiron Corp. with the FDA for Cannula, Nasal, For Oxygen.
Device ID | K760080 |
510k Number | K760080 |
Device Name: | CANNULA, NASAL, FOR OXYGEN |
Classification | Cannula, Nasal, Oxygen |
Applicant | INSPIRON CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CAT |
CFR Regulation Number | 868.5340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-06-21 |
Decision Date | 1976-07-15 |