The following data is part of a premarket notification filed by Merz North America, Inc. with the FDA for Describe Pfd Patch.
| Device ID | K172689 |
| 510k Number | K172689 |
| Device Name: | DESCRIBE PFD Patch |
| Classification | Transparent Patch For Use In Treatment Of Tattoos |
| Applicant | Merz North America, Inc. 6501 Six Forks Road Raleigh, NC 27615 |
| Contact | Misty D’ottavio |
| Correspondent | Misty D’ottavio Merz North America, Inc. 6501 Six Forks Road Raleigh, NC 27615 |
| Product Code | PKO |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-06 |
| Decision Date | 2017-11-29 |
| Summary: | summary |