The following data is part of a premarket notification filed by Pudenz-schulte Medical Research Corp. with the FDA for P-s Berlin Vessel Clamp.
| Device ID | K820949 |
| 510k Number | K820949 |
| Device Name: | P-S BERLIN VESSEL CLAMP |
| Classification | Clamp, Vascular |
| Applicant | PUDENZ-SCHULTE MEDICAL RESEARCH CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-04-06 |
| Decision Date | 1982-04-29 |