The following data is part of a premarket notification filed by Ohio Medical Instrument Co., Inc. with the FDA for Mayfield Radiolucent Skull Clamp.
| Device ID | K934289 |
| 510k Number | K934289 |
| Device Name: | MAYFIELD RADIOLUCENT SKULL CLAMP |
| Classification | Holder, Head, Neurosurgical (skull Clamp) |
| Applicant | OHIO MEDICAL INSTRUMENT CO., INC. 3924 VIRGINIA AVE. Cincinnati, OH 45227 |
| Contact | Dennis R Lackey |
| Correspondent | Dennis R Lackey OHIO MEDICAL INSTRUMENT CO., INC. 3924 VIRGINIA AVE. Cincinnati, OH 45227 |
| Product Code | HBL |
| CFR Regulation Number | 882.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-02 |
| Decision Date | 1994-01-07 |