The following data is part of a premarket notification filed by Clairol, Inc. with the FDA for Plaque Detection System.
| Device ID | K781919 |
| 510k Number | K781919 |
| Device Name: | PLAQUE DETECTION SYSTEM |
| Classification | Plaque Disclosing Kit |
| Applicant | CLAIROL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | NYH |
| CFR Regulation Number | 872.1740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-11-13 |
| Decision Date | 1978-12-04 |