The following data is part of a premarket notification filed by Ohio Medical Instrument Co., Inc. with the FDA for Omi Occipital Cervical Loop, Model A1089.
| Device ID | K983282 |
| 510k Number | K983282 |
| Device Name: | OMI OCCIPITAL CERVICAL LOOP, MODEL A1089 |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | OHIO MEDICAL INSTRUMENT CO., INC. 4900 CHARLEMAR DR. Cincinnati, OH 45227 |
| Contact | Kenneth B Miller |
| Correspondent | Kenneth B Miller OHIO MEDICAL INSTRUMENT CO., INC. 4900 CHARLEMAR DR. Cincinnati, OH 45227 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-18 |
| Decision Date | 1998-11-19 |
| Summary: | summary |