The following data is part of a premarket notification filed by Ohio Medical Instrument Co., Inc. with the FDA for Mayfield Radiolucent Skull Pins, Model 4-0-a-2020.
| Device ID | K021604 |
| 510k Number | K021604 |
| Device Name: | MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020 |
| Classification | Holder, Head, Neurosurgical (skull Clamp) |
| Applicant | OHIO MEDICAL INSTRUMENT CO., INC. 4900 CHARLEMAR DR. Cincinnati, OH 45227 |
| Contact | Charles E Dinkler Ii |
| Correspondent | Charles E Dinkler Ii OHIO MEDICAL INSTRUMENT CO., INC. 4900 CHARLEMAR DR. 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 | 2002-05-16 |
| Decision Date | 2002-07-29 |
| Summary: | summary |