The following data is part of a premarket notification filed by Warne Surgical Products, Ltd. with the FDA for Secure W/35mm Diam, Sheath/adhesive.
Device ID | K840704 |
510k Number | K840704 |
Device Name: | SECURE W/35MM DIAM, SHEATH/ADHESIVE |
Classification | Collector, Urine, (and Accessories) For Indwelling Catheter |
Applicant | WARNE SURGICAL PRODUCTS, LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KNX |
CFR Regulation Number | 876.5250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-02-17 |
Decision Date | 1984-03-22 |