The following data is part of a premarket notification filed by Pudenz-schulte Medical Research Corp. with the FDA for P-s Medical Berlin Visaduct Kit.
| Device ID | K832677 |
| 510k Number | K832677 |
| Device Name: | P-S MEDICAL BERLIN VISADUCT KIT |
| Classification | Surgical Instruments, G-u, Manual (and Accessories) |
| Applicant | PUDENZ-SCHULTE MEDICAL RESEARCH CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KOA |
| CFR Regulation Number | 876.4730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-09 |
| Decision Date | 1983-12-08 |