The following data is part of a premarket notification filed by Advanced Medical Technology, Inc. with the FDA for Model A-8000 Ultrasonic Handpiece Cord.
| Device ID | K862777 |
| 510k Number | K862777 |
| Device Name: | MODEL A-8000 ULTRASONIC HANDPIECE CORD |
| Classification | Unit, Phacofragmentation |
| Applicant | ADVANCED MEDICAL TECHNOLOGY, INC. 14 HUGHES STREET, STE B104 Irvine, CA 92718 |
| Contact | Thomas V Keeley |
| Correspondent | Thomas V Keeley ADVANCED MEDICAL TECHNOLOGY, INC. 14 HUGHES STREET, STE B104 Irvine, CA 92718 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-22 |
| Decision Date | 1986-08-11 |