The following data is part of a premarket notification filed by Pudenz-schulte Medical Research Corp. with the FDA for P-s Medical Csf-flow Control Valve-bur.
| Device ID | K831678 |
| 510k Number | K831678 |
| Device Name: | P-S MEDICAL CSF-FLOW CONTROL VALVE-BUR |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | PUDENZ-SCHULTE MEDICAL RESEARCH CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-23 |
| Decision Date | 1983-06-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994803573 | K831678 | 000 |
| 00643169466173 | K831678 | 000 |
| 00643169466166 | K831678 | 000 |
| 00673978249803 | K831678 | 000 |
| 00763000028060 | K831678 | 000 |
| 00763000027759 | K831678 | 000 |
| 00763000027742 | K831678 | 000 |
| 00763000027735 | K831678 | 000 |
| 00763000028862 | K831678 | 000 |
| 00763000028855 | K831678 | 000 |
| 00763000027896 | K831678 | 000 |
| 00763000027889 | K831678 | 000 |
| 00763000027872 | K831678 | 000 |
| 00643169466180 | K831678 | 000 |
| 00643169466333 | K831678 | 000 |
| 00613994803566 | K831678 | 000 |
| 00613994803559 | K831678 | 000 |
| 00643169073623 | K831678 | 000 |
| 00643169498365 | K831678 | 000 |
| 00643169472747 | K831678 | 000 |
| 00643169472730 | K831678 | 000 |
| 00643169466906 | K831678 | 000 |
| 00643169466579 | K831678 | 000 |
| 00643169466531 | K831678 | 000 |
| 00643169466364 | K831678 | 000 |
| 00643169466357 | K831678 | 000 |
| 00643169466340 | K831678 | 000 |
| 00763000027865 | K831678 | 000 |