K905460 is an FDA 510(k) clearance for the STERILE DISPOSABLE DRAPE/OPHTHALMIC SURGERY. This device is classified as a Drape, Patient, Ophthalmic (Class II - Special Controls, product code HMT).
Submitted by Angiosystems, Inc. (Great Neck, US). The FDA issued a Cleared decision on February 6, 1991, 63 days after receiving the submission on December 5, 1990.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K905460 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 05, 1990 |
| Decision Date | February 06, 1991 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | HMT — Drape, Patient, Ophthalmic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4370 |