The following data is part of a premarket notification filed by Ohio Medical Instrument Co., Inc. with the FDA for T19s Biopsy Needle.
| Device ID | K902077 |
| 510k Number | K902077 |
| Device Name: | T19S BIOPSY NEEDLE |
| Classification | Instrument, Biopsy |
| 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 | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-08 |
| Decision Date | 1990-07-27 |