The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Argyle Delee Suction Catheter W/mucous.
Device ID | K820572 |
510k Number | K820572 |
Device Name: | ARGYLE DELEE SUCTION CATHETER W/MUCOUS |
Classification | Tube, Aspirating, Bronchoscope, Rigid |
Applicant | SHERWOOD MEDICAL CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KTR |
CFR Regulation Number | 874.4680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-03-02 |
Decision Date | 1982-04-09 |