The following data is part of a premarket notification filed by Terumo Europe N.v. with the FDA for K-pack Surshield Needle, Hypodermic Needle For Single Use.
| Device ID | K110527 |
| 510k Number | K110527 |
| Device Name: | K-PACK SURSHIELD NEEDLE, HYPODERMIC NEEDLE FOR SINGLE USE |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-24 |
| Decision Date | 2011-06-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 55413206050265 | K110527 | 000 |