The following data is part of a premarket notification filed by American Optical Corp. with the FDA for Aoi Universal Ultrasonic Handpiece.
| Device ID | K950880 |
| 510k Number | K950880 |
| Device Name: | AOI UNIVERSAL ULTRASONIC HANDPIECE |
| Classification | Unit, Phacofragmentation |
| Applicant | AMERICAN OPTICAL CORP. 19 HAMMOND SUITE 505 Irvine, CA 92718 |
| Contact | Glenn A Dunki-jacobs |
| Correspondent | Glenn A Dunki-jacobs AMERICAN OPTICAL CORP. 19 HAMMOND SUITE 505 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 | 1995-02-27 |
| Decision Date | 1995-05-26 |