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 |