The following data is part of a premarket notification filed by Carefusion 209, Inc. with the FDA for Teca (tm) Elite Disposable Monopolar Needles.
| Device ID | K111131 |
| 510k Number | K111131 |
| Device Name: | TECA (TM) ELITE DISPOSABLE MONOPOLAR 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 | 2011-04-21 |
| Decision Date | 2011-06-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830028943 | K111131 | 000 |
| 00382830028837 | K111131 | 000 |
| 00382830028844 | K111131 | 000 |
| 00382830028851 | K111131 | 000 |
| 00382830028868 | K111131 | 000 |
| 00382830028875 | K111131 | 000 |
| 00382830028882 | K111131 | 000 |
| 00382830028899 | K111131 | 000 |
| 00382830028905 | K111131 | 000 |
| 00382830028912 | K111131 | 000 |
| 00382830028929 | K111131 | 000 |
| 00382830028936 | K111131 | 000 |
| 00382830028820 | K111131 | 000 |