The following data is part of a premarket notification filed by Pudenz-schulte Medical Research Corp. with the FDA for P-s Med. Lumbo Peritoneal & Ventriculo-.
| Device ID | K823509 |
| 510k Number | K823509 |
| Device Name: | P-S MED. LUMBO PERITONEAL & VENTRICULO- |
| 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 | 1982-11-26 |
| Decision Date | 1982-12-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169498341 | K823509 | 000 |
| 00643169497948 | K823509 | 000 |
| 00673978229829 | K823509 | 000 |
| 00673978229799 | K823509 | 000 |
| 00763000260026 | K823509 | 000 |
| 00763000260019 | K823509 | 000 |