The following data is part of a premarket notification filed by Pudenz-schulte Medical Research Corp. with the FDA for P-s Csf-ventricular Catheter, Flanged.
| Device ID | K823503 |
| 510k Number | K823503 |
| Device Name: | P-S CSF-VENTRICULAR CATHETER, FLANGED |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | PUDENZ-SCHULTE MEDICAL RESEARCH CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-11-24 |
| Decision Date | 1983-03-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169472785 | K823503 | 000 |
| 00643169472716 | K823503 | 000 |
| 00763000028831 | K823503 | 000 |