510(k) K172689
- Device
- DESCRIBE PFD Patch
- Applicant
- Merz North America, Inc.
- 510(k) number
- K172689
- Product code
- PKO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-11-29
- Date received
- 2017-09-06
- Regulation
- 878.4810
- Classification name
- Transparent Patch For Use In Treatment Of Tattoos
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Misty D’Ottavio
- Address
- 6501 Six Forks Rd. Raleigh NC US 27615 27615
FDA Registration Numbers#
- 3011310987
- 2135225
- 3013840437
Source Documents#
Other 510(k) Records For Product Code PKO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K150212 | DeScribe Transparent PFD Patch | On Light Sciences, Inc. | 2015-04-20 |
Legacy Summary#
summary
FDA Review#
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