The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Monoject Blunt I.v. Access Cannula/monoject Hypodermic Syringe With Blunt I.v. Access Cannula.
| Device ID | K960982 |
| 510k Number | K960982 |
| Device Name: | MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT I.V. ACCESS CANNULA |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1642 |
| Contact | Cherly Winters-heard |
| Correspondent | Cherly Winters-heard SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1642 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-11 |
| Decision Date | 1996-12-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521106413 | K960982 | 000 |
| 20884521082462 | K960982 | 000 |
| 20884521082950 | K960982 | 000 |
| 20884521082912 | K960982 | 000 |