The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Argle Latex Penrose Tubing.
Device ID | K802286 |
510k Number | K802286 |
Device Name: | ARGLE LATEX PENROSE TUBING |
Classification | Accessories, Catheter |
Applicant | SHERWOOD MEDICAL CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KGZ |
CFR Regulation Number | 878.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-09-19 |
Decision Date | 1980-10-23 |