The following data is part of a premarket notification filed by Piedmont Pharmaceuticals, Llc with the FDA for Resultz Lice & Egg Removal Kit.
Device ID | K151562 |
510k Number | K151562 |
Device Name: | Resultz Lice & Egg Removal Kit |
Classification | Detectors And Removers, Lice, (including Combs) |
Applicant | Piedmont Pharmaceuticals, LLC 204 Muirs Chapel Road, Ste 200 Greensboro, NC 27410 |
Contact | Kathleen G. Palma |
Correspondent | Diane Sudduth Compliance Architects 100 Horizon Center Boulevard, Suite 234 Hamilton, NJ 08691 |
Product Code | LJL |
CFR Regulation Number | 880.5960 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-06-10 |
Decision Date | 2017-05-08 |