K960261 is an FDA 510(k) clearance for the PALLIKARIS BRUSH. This device is classified as a Burr, Corneal, Battery-powered (Class I - General Controls, product code HOG).
Submitted by Alcon Laboratories, Inc. (Orlando, US). The FDA issued a Cleared decision on March 11, 1996, 53 days after receiving the submission on January 18, 1996.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4070.
| 510(k) Number | K960261 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 18, 1996 |
| Decision Date | March 11, 1996 |
| Days to Decision | 53 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
| Product Code | HOG — Burr, Corneal, Battery-powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.4070 |