The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Monoject Soft Tissue Biopsy/fine Needle.
| Device ID | K840354 |
| 510k Number | K840354 |
| Device Name: | MONOJECT SOFT TISSUE BIOPSY/FINE NEEDLE |
| Classification | Biopsy Needle |
| Applicant | SHERWOOD MEDICAL CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FCG |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-26 |
| Decision Date | 1984-03-12 |