The following data is part of a premarket notification filed by Soniquence, Llc with the FDA for Soniquence Reusable 3 Button Fingerswitch Wand.
Device ID | K212222 |
510k Number | K212222 |
Device Name: | Soniquence Reusable 3 Button Fingerswitch Wand |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | Soniquence, LLC 2477 Grand Avenue Baldwin, NY 11510 |
Contact | Suzanne Lucas |
Correspondent | Suzanne Lucas Soniquence, LLC 2477 Grand Avenue Baldwin, NY 11510 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-07-16 |
Decision Date | 2022-09-02 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00810026180972 | K212222 | 000 |