The following data is part of a premarket notification filed by Carol Cole Company with the FDA for Trinity Wrinkle Remover.
| Device ID | K120560 |
| 510k Number | K120560 |
| Device Name: | TRINITY WRINKLE REMOVER |
| Classification | Light Based Over The Counter Wrinkle Reduction |
| 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 | OHS |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-24 |
| Decision Date | 2012-11-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810075940237 | K120560 | 000 |
| 00810075940213 | K120560 | 000 |