The following data is part of a premarket notification filed by Ohio Medical Instrument Co., Inc. with the FDA for Mayfield/acciss Operating Arm System And Mayfield/optical Acciss System.
| Device ID | K013428 |
| 510k Number | K013428 |
| Device Name: | MAYFIELD/ACCISS OPERATING ARM SYSTEM AND MAYFIELD/OPTICAL ACCISS SYSTEM |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | OHIO MEDICAL INSTRUMENT CO., INC. 10 OAK POINT Wrentham, MA 02093 |
| Contact | Donald A Lincoln |
| Correspondent | Donald A Lincoln OHIO MEDICAL INSTRUMENT CO., INC. 10 OAK POINT Wrentham, MA 02093 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-16 |
| Decision Date | 2002-04-04 |
| Summary: | summary |