The following data is part of a premarket notification filed by Coopervision, Inc. with the FDA for Cavitron/kelman Phacoemulsifier Aspirator, Univ..
| Device ID | K890635 |
| 510k Number | K890635 |
| Device Name: | CAVITRON/KELMAN PHACOEMULSIFIER ASPIRATOR, UNIV. |
| Classification | Unit, Phacofragmentation |
| Applicant | COOPERVISION, INC. 17701 COWAN AVE.P. O. BOX 19587 Irvine, CA 92713 |
| Contact | Dave Krapf |
| Correspondent | Dave Krapf COOPERVISION, INC. 17701 COWAN AVE.P. O. BOX 19587 Irvine, CA 92713 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-08 |
| Decision Date | 1989-05-09 |