The following data is part of a premarket notification filed by Ohio Medical Instrument Co., Inc. with the FDA for Tew Cranial/spinal Retractor Model A1090.
| Device ID | K960807 |
| 510k Number | K960807 |
| Device Name: | TEW CRANIAL/SPINAL RETRACTOR MODEL A1090 |
| Classification | Retractor, Self-retaining, For Neurosurgery |
| Applicant | OHIO MEDICAL INSTRUMENT CO., INC. 3924 VIRGINIA AVE. Cincinnati, OH 45227 |
| Contact | F. William Sweet |
| Correspondent | F. William Sweet OHIO MEDICAL INSTRUMENT CO., INC. 3924 VIRGINIA AVE. Cincinnati, OH 45227 |
| Product Code | GZT |
| CFR Regulation Number | 882.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-28 |
| Decision Date | 1996-05-17 |
| Summary: | summary |