The following data is part of a premarket notification filed by Pudenz-schulte Medical Research Corp. with the FDA for Ps Medical Cranial Hand Drill.
| Device ID | K904283 |
| 510k Number | K904283 |
| Device Name: | PS MEDICAL CRANIAL HAND DRILL |
| Classification | Drills, Burrs, Trephines & Accessories (manual) |
| Applicant | PUDENZ-SCHULTE MEDICAL RESEARCH CORP. P.O. BOX 2090 Goleta, CA 93118 |
| Contact | Stephen Laguette |
| Correspondent | Stephen Laguette 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 | 1990-09-17 |
| Decision Date | 1990-10-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169498457 | K904283 | 000 |