The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Monoject Sterile M216 Blood Collection Needles.
| Device ID | K854548 |
| 510k Number | K854548 |
| Device Name: | MONOJECT STERILE M216 BLOOD COLLECTION NEEDLES |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1625 |
| Contact | Fucile, Jr. |
| Correspondent | Fucile, Jr. SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1625 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-13 |
| Decision Date | 1986-02-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521139923 | K854548 | 000 |
| 20884521139913 | K854548 | 000 |