The following data is part of a premarket notification filed by Adp Intl., Inc. with the FDA for Hand Instruments.
| Device ID | K760985 |
| 510k Number | K760985 |
| Device Name: | HAND INSTRUMENTS |
| Classification | Broach, Endodontic |
| Applicant | ADP INTL., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EKW |
| 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 |