The following data is part of a premarket notification filed by Pudenz-schulte Medical Research Corp. with the FDA for Csf-flow Control Valve, Cylindrical & Shunt Kit.
| Device ID | K900676 |
| 510k Number | K900676 |
| Device Name: | CSF-FLOW CONTROL VALVE, CYLINDRICAL & SHUNT KIT |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | PUDENZ-SCHULTE MEDICAL RESEARCH CORP. P.O. BOX 2090 Goleta, CA 93118 |
| Contact | W Laguette |
| Correspondent | W Laguette PUDENZ-SCHULTE MEDICAL RESEARCH CORP. P.O. BOX 2090 Goleta, CA 93118 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-12 |
| Decision Date | 1990-04-03 |