The following data is part of a premarket notification filed by Smiths Medical Asd, Inc. with the FDA for Hypodermic Needle-pro Edge Needle Protection Device.
| Device ID | K041399 |
| 510k Number | K041399 |
| Device Name: | HYPODERMIC NEEDLE-PRO EDGE NEEDLE PROTECTION DEVICE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | SMITHS MEDICAL ASD, INC. 10 BOWMAN DR. Keene, NH 03431 |
| Contact | Brian D Farias |
| Correspondent | Brian D Farias SMITHS MEDICAL ASD, INC. 10 BOWMAN DR. Keene, NH 03431 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-26 |
| Decision Date | 2004-07-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30351688066545 | K041399 | 000 |
| 30351688066538 | K041399 | 000 |
| 30351688066521 | K041399 | 000 |
| 55019517065815 | K041399 | 000 |
| 35019517065781 | K041399 | 000 |
| 35019517065767 | K041399 | 000 |