The following data is part of a premarket notification filed by Coopervision, Inc. with the FDA for Series Ten Thousand Ocutome.
| Device ID | K871871 |
| 510k Number | K871871 |
| Device Name: | SERIES TEN THOUSAND OCUTOME |
| Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Applicant | COOPERVISION, INC. 17701 COWAN AVE.P. O. BOX 19587 Irvine, CA 92713 |
| Contact | David W Krapf |
| Correspondent | David W Krapf COOPERVISION, INC. 17701 COWAN AVE.P. O. BOX 19587 Irvine, CA 92713 |
| Product Code | HQE |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-13 |
| Decision Date | 1987-06-11 |