The following data is part of a premarket notification filed by Sketchpad Innovations Llc with the FDA for Kava And Kava With Herbst.
Device ID | K182661 |
510k Number | K182661 |
Device Name: | Kava And Kava With Herbst |
Classification | Device, Anti-snoring |
Applicant | Sketchpad Innovations LLC 10767 Glendover Ln. San Diego, CA 92126 |
Contact | Phillip "sonnie" Bocala |
Correspondent | Cheryl Fisher FisherMed Consulting LLC 820 Civic Center Dr. Santa Clara, CA 95050 |
Product Code | LRK |
CFR Regulation Number | 872.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-09-25 |
Decision Date | 2019-02-13 |
Summary: | summary |