The following data is part of a premarket notification filed by American Hospital Supply Corp. with the FDA for Heyer-schute Universal Ureteral Stent.
| Device ID | K823418 |
| 510k Number | K823418 |
| Device Name: | HEYER-SCHUTE UNIVERSAL URETERAL STENT |
| Classification | Catheter, Nephrostomy |
| Applicant | AMERICAN HOSPITAL SUPPLY CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| 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 | 1982-11-15 |
| Decision Date | 1982-12-03 |