The following data is part of a premarket notification filed by Larada Sciences with the FDA for Lousebuster.
Device ID | K083206 |
510k Number | K083206 |
Device Name: | LOUSEBUSTER |
Classification | Detectors And Removers, Lice, (including Combs) |
Applicant | LARADA SCIENCES 148 S. 1200 E. Salt Lake City, UT 84102 -1643 |
Contact | Phil Triolo |
Correspondent | Phil Triolo LARADA SCIENCES 148 S. 1200 E. Salt Lake City, UT 84102 -1643 |
Product Code | LJL |
CFR Regulation Number | 880.5960 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-10-31 |
Decision Date | 2009-03-10 |
Summary: | summary |