The following data is part of a premarket notification filed by E-z-em, Inc. with the FDA for E-z-em Single Stick Puncture/drainage.
| Device ID | K842121 |
| 510k Number | K842121 |
| Device Name: | E-Z-EM SINGLE STICK PUNCTURE/DRAINAGE |
| Classification | Catheter, Nephrostomy |
| Applicant | E-Z-EM, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LJE |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-29 |
| Decision Date | 1984-10-01 |