The following data is part of a premarket notification filed by Convatec, A Division Of E.r. Squibb & Sons with the FDA for Sur-fit Night Drainage Container Set.
Device ID | K842395 |
510k Number | K842395 |
Device Name: | SUR-FIT NIGHT DRAINAGE CONTAINER SET |
Classification | Collector, Urine, (and Accessories) For Indwelling Catheter |
Applicant | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS 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 | 1984-06-19 |
Decision Date | 1984-08-08 |