The following data is part of a premarket notification filed by Covidien Llc with the FDA for Valleylab Rem Polyhesive Infant Patient Return Electrode.
| Device ID | K160290 |
| 510k Number | K160290 |
| Device Name: | Valleylab REM Polyhesive Infant Patient Return Electrode |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Covidien LLC 5920 LONGBOW DRIVE Boulder, CO 80301 |
| Contact | Nancy Sauer |
| Correspondent | Nancy Sauer Covidien LLC 5920 LONGBOW DRIVE Boulder, CO 80301 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-03 |
| Decision Date | 2016-05-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884524001057 | K160290 | 000 |
| 20884524001040 | K160290 | 000 |