The following data is part of a premarket notification filed by Terumo Europe N.v. with the FDA for K-pack Ii Needle - 29g X 5/16 Thin Wall.
| Device ID | K151398 |
| 510k Number | K151398 |
| Device Name: | K-Pack II Needle - 29G X 5/16 Thin Wall |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | TERUMO EUROPE N.V. Interleuvenlaan 40 Leuven, BE 3001 |
| Contact | M. J. Aerts |
| Correspondent | M. J. Aerts TERUMO EUROPE N.V. Interleuvenlaan 40 Leuven, BE 3001 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-26 |
| Decision Date | 2015-06-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05413206211050 | K151398 | 000 |