The following data is part of a premarket notification filed by Vance Products, Inc. with the FDA for Vance Percutaneous Malecot Nephrostomy.
Device ID | K810368 |
510k Number | K810368 |
Device Name: | VANCE PERCUTANEOUS MALECOT NEPHROSTOMY |
Classification | Catheter, Suprapubic (and Accessories) |
Applicant | VANCE PRODUCTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | KOB |
CFR Regulation Number | 876.5090 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-02-12 |
Decision Date | 1981-03-20 |