The following data is part of a premarket notification filed by Convatec, A Division Of E.r. Squibb & Sons with the FDA for Accuseal Leg Bags & Extension Tubes.
| Device ID | K842396 |
| 510k Number | K842396 |
| Device Name: | ACCUSEAL LEG BAGS & EXTENSION TUBES |
| 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 |