The following data is part of a premarket notification filed by P-s Medical with the FDA for P-s Medical Csf-flow Control Valve-.
Device ID | K841442 |
510k Number | K841442 |
Device Name: | P-S MEDICAL CSF-FLOW CONTROL VALVE- |
Classification | Shunt, Central Nervous System And Components |
Applicant | P-S MEDICAL 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 | 1984-04-06 |
Decision Date | 1984-04-19 |