The following data is part of a premarket notification filed by Coopervision, Inc. with the FDA for Smartknife System.
| Device ID | K853063 |
| 510k Number | K853063 |
| Device Name: | SMARTKNIFE SYSTEM |
| Classification | Knife, Ophthalmic |
| 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 | HNN |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-19 |
| Decision Date | 1985-11-04 |