The following data is part of a premarket notification filed by Buckman Co., Inc. with the FDA for Cci Corneal Scarifier.
| Device ID | K904505 |
| 510k Number | K904505 |
| Device Name: | CCI CORNEAL SCARIFIER |
| Classification | Scalpel, One-piece |
| Applicant | BUCKMAN CO., INC. 1000 BURNETT AVE. SUITE 450 Concord, CA 94520 |
| Contact | David Schlerf |
| Correspondent | David Schlerf BUCKMAN CO., INC. 1000 BURNETT AVE. SUITE 450 Concord, CA 94520 |
| Product Code | GDX |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-02 |
| Decision Date | 1991-04-23 |