The following data is part of a premarket notification filed by Pudenz-schulte Medical Research Corp. with the FDA for P-s Medical Csf-lumboperitoneal Shunt.
| Device ID | K831396 |
| 510k Number | K831396 |
| Device Name: | P-S MEDICAL CSF-LUMBOPERITONEAL SHUNT |
| 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 | 1983-04-29 |
| Decision Date | 1983-08-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994800701 | K831396 | 000 |
| 00763000027766 | K831396 | 000 |
| 00763000029623 | K831396 | 000 |
| 00763000027247 | K831396 | 000 |
| 00763000027582 | K831396 | 000 |
| 00763000028107 | K831396 | 000 |
| 00763000030827 | K831396 | 000 |
| 00673978228471 | K831396 | 000 |
| 00673978237602 | K831396 | 000 |
| 00643169466197 | K831396 | 000 |
| 00643169466203 | K831396 | 000 |
| 00643169472365 | K831396 | 000 |
| 00643169483507 | K831396 | 000 |
| 00643169073630 | K831396 | 000 |
| 00643169073678 | K831396 | 000 |
| 00763000027599 | K831396 | 000 |