K904505 is an FDA 510(k) clearance for the CCI CORNEAL SCARIFIER. This device is classified as a Scalpel, One-piece (Class I - General Controls, product code GDX).
Submitted by Buckman Co., Inc. (Concord, US). The FDA issued a Cleared decision on April 23, 1991, 203 days after receiving the submission on October 2, 1990.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K904505 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 02, 1990 |
| Decision Date | April 23, 1991 |
| Days to Decision | 203 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GDX — Scalpel, One-piece |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |