The following data is part of a premarket notification filed by Terumo Europe N.v. with the FDA for 29g And 30g K-pack Ii Needle.
| Device ID | K062608 |
| 510k Number | K062608 |
| Device Name: | 29G AND 30G K-PACK II NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | TERUMO EUROPE N.V. INTERLEUVENLAAN 40 RESEARCHPARK ZONE 2 Leuven, BE 3001 |
| Contact | M.j. Aerts |
| Correspondent | M.j. Aerts TERUMO EUROPE N.V. INTERLEUVENLAAN 40 RESEARCHPARK ZONE 2 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 | 2006-09-05 |
| Decision Date | 2006-09-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 55413206037082 | K062608 | 000 |
| 05413206034338 | K062608 | 000 |
| 55413206034326 | K062608 | 000 |