The following data is part of a premarket notification filed by Vance Products, Inc. with the FDA for Vance Prostatic Aspiration Set.
| Device ID | K811454 |
| 510k Number | K811454 |
| Device Name: | VANCE PROSTATIC ASPIRATION SET |
| Classification | Instrument, Biopsy |
| Applicant | VANCE PRODUCTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-05-22 |
| Decision Date | 1981-06-09 |