The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Argyle Nasal Cannula.
Device ID | K833127 |
510k Number | K833127 |
Device Name: | ARGYLE NASAL CANNULA |
Classification | Cannula, Nasal, Oxygen |
Applicant | SHERWOOD MEDICAL CO. 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 | 1983-09-13 |
Decision Date | 1983-11-03 |