The following data is part of a premarket notification filed by Vance Products, Inc. with the FDA for Vance Cystoscopic.
| Device ID | K812057 |
| 510k Number | K812057 |
| Device Name: | VANCE CYSTOSCOPIC |
| Classification | Endoscopic Injection Needle, Gastroenterology-urology |
| Applicant | VANCE PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FBK |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-07-21 |
| Decision Date | 1981-07-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00827002152960 | K812057 | 000 |
| 00827002152762 | K812057 | 000 |
| 00827002142206 | K812057 | 000 |
| 00827002162693 | K812057 | 000 |
| 00827002158641 | K812057 | 000 |