The following data is part of a premarket notification filed by Coopervision, Inc. with the FDA for Micro Cise Diamond Scalpel.
| Device ID | K820730 |
| 510k Number | K820730 |
| Device Name: | MICRO CISE DIAMOND SCALPEL |
| Classification | Scalpel, One-piece |
| Applicant | COOPERVISION, INC. PERMALENS HOUSE 1 BOTLEY ROAD, HEDGE END Southampton, GB S033hb |
| Product Code | GDX |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-03-17 |
| Decision Date | 1982-04-09 |