The following data is part of a premarket notification filed by Terumo Europe N.v. with the FDA for K-pack Ii Needle - 27g X 1/2” Extra Thin Wall, K-pack Ii Needle - 27g X 1/2” Ultra Thin Wall, K-pack Ii Needle - 30g X 1/2” Extra Thin Wall, K-pack Ii Needle - 30g X 1/2” Ultra Thin Wall.
| Device ID | K192057 |
| 510k Number | K192057 |
| Device Name: | K-Pack II Needle - 27G X 1/2” Extra Thin Wall, K-Pack II Needle - 27G X 1/2” Ultra Thin Wall, K-Pack II Needle - 30G X 1/2” Extra Thin Wall, K-Pack II Needle - 30G X 1/2” Ultra 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 | 2019-08-01 |
| Decision Date | 2019-10-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 55413206219174 | K192057 | 000 |
| 55413206219167 | K192057 | 000 |
| 55413206219150 | K192057 | 000 |
| 55413206219136 | K192057 | 000 |