The following data is part of a premarket notification filed by Clinical Neuro Systems Llc. with the FDA for Clinical Neuro Systems Cranial Drill.
| Device ID | K930229 |
| 510k Number | K930229 |
| Device Name: | CLINICAL NEURO SYSTEMS CRANIAL DRILL |
| Classification | Drills, Burrs, Trephines & Accessories (simple, Powered) |
| Applicant | CLINICAL NEURO SYSTEMS LLC. 875 NORMA WAY Santa Barbara, CA 93111 |
| Contact | Stephen W Laguette |
| Correspondent | Stephen W Laguette CLINICAL NEURO SYSTEMS LLC. 875 NORMA WAY Santa Barbara, CA 93111 |
| Product Code | HBE |
| CFR Regulation Number | 882.4310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-19 |
| Decision Date | 1993-03-16 |