PS MEDICAL VENTRICULOSTOMY KIT
Device Facts
| Record ID | K915546 |
|---|---|
| Device Name | PS MEDICAL VENTRICULOSTOMY KIT |
| Applicant | Pudenz-Schulte Medical Research Corp. |
| Product Code | HBG · Neurology |
| Decision Date | Dec 30, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.4300 |
| Device Class | Class 2 |
Regulatory Classification
Identification
Manual cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments that are used without a power source on a patient's skull.
