The following data is part of a premarket notification filed by Terumo Europe N.v. with the FDA for K-pack Ii (hypodermic Needle) 23g X 1, Model Kn-2325rb, K-pack Ii Needle (hypodermic Needle) 25g X 1, Model Kn-2525rb, K.
| Device ID | K984576 |
| 510k Number | K984576 |
| Device Name: | K-PACK II (HYPODERMIC NEEDLE) 23G X 1, MODEL KN-2325RB, K-PACK II NEEDLE (HYPODERMIC NEEDLE) 25G X 1, MODEL KN-2525RB, K |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | TERUMO EUROPE N.V. RESEARCHPARK ZONE 2 INTERLEUVENLAAN 40 Leuven 3001, BE 3001 |
| Contact | M J Aerts |
| Correspondent | M J Aerts TERUMO EUROPE N.V. RESEARCHPARK ZONE 2 INTERLEUVENLAAN 40 Leuven 3001, BE 3001 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-23 |
| Decision Date | 1999-06-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 55413206216739 | K984576 | 000 |
| 55413206031318 | K984576 | 000 |
| 55413206031165 | K984576 | 000 |
| 05413206025053 | K984576 | 000 |
| 55413206020541 | K984576 | 000 |
| 55413206018142 | K984576 | 000 |
| 55413206003810 | K984576 | 000 |
| 55413206003803 | K984576 | 000 |
| 55413206003797 | K984576 | 000 |
| 55413206003780 | K984576 | 000 |
| 35413206248217 | K984576 | 000 |
| 55413206031745 | K984576 | 000 |
| 05413206031771 | K984576 | 000 |
| 55413206031868 | K984576 | 000 |
| 55413206216722 | K984576 | 000 |
| 55413206211130 | K984576 | 000 |
| 55413206203555 | K984576 | 000 |
| 55413206203548 | K984576 | 000 |
| 55413206052672 | K984576 | 000 |
| 55413206033206 | K984576 | 000 |
| 55413206032667 | K984576 | 000 |
| 55413206032650 | K984576 | 000 |
| 55413206032643 | K984576 | 000 |
| 05413206032037 | K984576 | 000 |
| 55413206256537 | K984576 | 000 |