The following data is part of a premarket notification filed by Gyneco, Inc. with the FDA for Fine Needle Aspiration Device.
| Device ID | K841275 |
| 510k Number | K841275 |
| Device Name: | FINE NEEDLE ASPIRATION DEVICE |
| Classification | Compressor, Cardiac, External |
| Applicant | GYNECO, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DRM |
| CFR Regulation Number | 870.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-03-27 |
| Decision Date | 1984-08-17 |