The following data is part of a premarket notification filed by Adp Intl., Inc. with the FDA for Orthodontic Instruments.
Device ID | K760984 |
510k Number | K760984 |
Device Name: | ORTHODONTIC INSTRUMENTS |
Classification | Plier, Orthodontic |
Applicant | ADP INTL., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JEX |
CFR Regulation Number | 872.4565 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-10-21 |
Decision Date | 1976-11-15 |