The following data is part of a premarket notification filed by Davis & Geck, Inc. with the FDA for Monojectt Bluntip I.v. Access Cannula With Vial Access Pin Device.
| Device ID | K980062 |
| 510k Number | K980062 |
| Device Name: | MONOJECTT BLUNTIP I.V. ACCESS CANNULA WITH VIAL ACCESS PIN DEVICE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | DAVIS & GECK, INC. 444 MC DONNELL BLVD. Hazelwood, MO 63042 |
| Contact | Stephen J Tarnsett |
| Correspondent | Stephen J Tarnsett DAVIS & GECK, INC. 444 MC DONNELL BLVD. Hazelwood, MO 63042 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-07 |
| Decision Date | 1998-03-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521082929 | K980062 | 000 |
| 30884521082971 | K980062 | 000 |