The following data is part of a premarket notification filed by Terumo Europe N.v. with the FDA for K-pack Ii Needle - 29g Thin Wall.
| Device ID | K082820 |
| 510k Number | K082820 |
| Device Name: | K-PACK II NEEDLE - 29G THIN WALL |
| 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 | 2008-09-25 |
| Decision Date | 2008-10-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 55413206042314 | K082820 | 000 |