The following data is part of a premarket notification filed by Carol Cole Company with the FDA for Nuface Plus.
| Device ID | K103472 |
| 510k Number | K103472 |
| Device Name: | NUFACE PLUS |
| Classification | Stimulator, Transcutaneous Electrical, Aesthetic Purposes |
| Applicant | Carol Cole Company 16405 SUMMER SAGE RD Poway, CA 92064 |
| Contact | Bob Duffy |
| Correspondent | Bob Duffy Carol Cole Company 16405 SUMMER SAGE RD Poway, CA 92064 |
| Product Code | NFO |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-24 |
| Decision Date | 2011-11-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850004079515 | K103472 | 000 |