The following data is part of a premarket notification filed by Engler Engineering Corp. with the FDA for Engler 25k Series Ultrasonic Inserts.
Device ID | K122748 |
510k Number | K122748 |
Device Name: | ENGLER 25K SERIES ULTRASONIC INSERTS |
Classification | Scaler, Ultrasonic |
Applicant | ENGLER ENGINEERING CORP. 1099 EAST 47TH ST. Hialeah, FL 33013 |
Contact | Joel Katz |
Correspondent | Joel Katz ENGLER ENGINEERING CORP. 1099 EAST 47TH ST. Hialeah, FL 33013 |
Product Code | ELC |
CFR Regulation Number | 872.4850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-09-07 |
Decision Date | 2013-06-11 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00636266958702 | K122748 | 000 |
00636266958306 | K122748 | 000 |