The following data is part of a premarket notification filed by California Technics, Inc. with the FDA for Sonus V.
Device ID | K811396 |
510k Number | K811396 |
Device Name: | SONUS V |
Classification | Scaler, Ultrasonic |
Applicant | CALIFORNIA TECHNICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | ELC |
CFR Regulation Number | 872.4850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-05-18 |
Decision Date | 1981-06-26 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00636266958337 | K811396 | 000 |
00862872000317 | K811396 | 000 |
00862872000324 | K811396 | 000 |
00862872000331 | K811396 | 000 |
00862872000348 | K811396 | 000 |
00862872000355 | K811396 | 000 |
00862872000362 | K811396 | 000 |
00862872000379 | K811396 | 000 |
00636266957262 | K811396 | 000 |
00862872000300 | K811396 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() SONUS V 73715714 1537319 Dead/Cancelled |
ENGLER ENGINEERING CORPORATION 1988-03-09 |