The following data is part of a premarket notification filed by Pudenz-schulte Medical Research Corp. with the FDA for Ps Medical Ventriculostomy Kit.
| Device ID | K915546 |
| 510k Number | K915546 |
| Device Name: | PS MEDICAL VENTRICULOSTOMY KIT |
| Classification | Drills, Burrs, Trephines & Accessories (manual) |
| Applicant | PUDENZ-SCHULTE MEDICAL RESEARCH CORP. P.O. BOX 2090 Goleta, CA 93118 |
| Contact | Tom Holdych |
| Correspondent | Tom Holdych PUDENZ-SCHULTE MEDICAL RESEARCH CORP. P.O. BOX 2090 Goleta, CA 93118 |
| Product Code | HBG |
| CFR Regulation Number | 882.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-11 |
| Decision Date | 1991-12-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00673978947402 | K915546 | 000 |
| 00673978947396 | K915546 | 000 |