The following data is part of a premarket notification filed by Carefusion 209, Inc. with the FDA for Teca Elite Disposable Concentric Needles.
| Device ID | K112034 |
| 510k Number | K112034 |
| Device Name: | TECA ELITE DISPOSABLE CONCENTRIC NEEDLES |
| Classification | Electrode, Needle, Diagnostic Electromyograph |
| Applicant | CAREFUSION 209, INC. 1850 Deming Way Middleton, WI 53562 |
| Contact | Glen Hermanson |
| Correspondent | Glen Hermanson CAREFUSION 209, INC. 1850 Deming Way Middleton, WI 53562 |
| Product Code | IKT |
| CFR Regulation Number | 890.1385 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-15 |
| Decision Date | 2011-08-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830028646 | K112034 | 000 |
| 05704736002875 | K112034 | 000 |
| 05704736002882 | K112034 | 000 |
| 05704736002899 | K112034 | 000 |
| 00382830017480 | K112034 | 000 |
| 00382830017497 | K112034 | 000 |
| 00382830017503 | K112034 | 000 |
| 00382830017510 | K112034 | 000 |
| 00382830017527 | K112034 | 000 |
| 00382830028608 | K112034 | 000 |
| 00382830028615 | K112034 | 000 |
| 00382830028622 | K112034 | 000 |
| 00382830028639 | K112034 | 000 |
| 05704736002868 | K112034 | 000 |