The following data is part of a premarket notification filed by Coopervision, Inc. with the FDA for Resubmitted Diode Laser Coagulator.
| Device ID | K882372 |
| 510k Number | K882372 |
| Device Name: | RESUBMITTED DIODE LASER COAGULATOR |
| Classification | Laser, Ophthalmic |
| Applicant | COOPERVISION, INC. 17701 COWAN AVE.P. O. BOX 19587 Irvine, CA 92713 |
| Contact | David Krapf |
| Correspondent | David Krapf COOPERVISION, INC. 17701 COWAN AVE.P. O. BOX 19587 Irvine, CA 92713 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-26 |
| Decision Date | 1988-08-02 |