The following data is part of a premarket notification filed by Innomed Corp. with the FDA for Innomed Pd-1 Kit.
Device ID | K822574 |
510k Number | K822574 |
Device Name: | INNOMED PD-1 KIT |
Classification | Detectors And Removers, Lice, (including Combs) |
Applicant | INNOMED CORP. 2629 DURANT OAKS DR. Valrico, FL 33594 |
Product Code | LJL |
CFR Regulation Number | 880.5960 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-08-24 |
Decision Date | 1982-10-13 |