The following data is part of a premarket notification filed by American Edwards Laboratories with the FDA for Diaflex Nephrostomy Balloon Dilator.
| Device ID | K842206 |
| 510k Number | K842206 |
| Device Name: | DIAFLEX NEPHROSTOMY BALLOON DILATOR |
| Classification | Dilator, Catheter, Ureteral |
| Applicant | AMERICAN EDWARDS LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EZN |
| CFR Regulation Number | 876.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-06-04 |
| Decision Date | 1984-10-02 |