The following data is part of a premarket notification filed by V. Mueller Neuro/spine with the FDA for Psi Skull Clamp.
| Device ID | K002276 |
| 510k Number | K002276 |
| Device Name: | PSI SKULL CLAMP |
| Classification | Holder, Head, Neurosurgical (skull Clamp) |
| Applicant | V. MUELLER NEURO/SPINE 360 INDUSTRIAL RD., UNIT H San Carlos, CA 94070 |
| Contact | Gary Cooper |
| Correspondent | Gary Cooper V. MUELLER NEURO/SPINE 360 INDUSTRIAL RD., UNIT H San Carlos, CA 94070 |
| Product Code | HBL |
| CFR Regulation Number | 882.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-26 |
| Decision Date | 2000-08-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 70885403111510 | K002276 | 000 |
| 70885403056897 | K002276 | 000 |
| 70885403056880 | K002276 | 000 |