The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Monoject Menghini Soft Tissue Biopsy.
| Device ID | K843264 |
| 510k Number | K843264 |
| Device Name: | MONOJECT MENGHINI SOFT TISSUE BIOPSY |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | SHERWOOD MEDICAL CO. 1831 OLIVE ST. St. Louis, MS 63103 |
| Contact | Frank J Fucile |
| Correspondent | Frank J Fucile SHERWOOD MEDICAL CO. 1831 OLIVE ST. St. Louis, MS 63103 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-20 |
| Decision Date | 1984-12-17 |