K864065 is an FDA 510(k) clearance for the BKS-42 DISPOSABLE VACUUM TUBING PACK. This device is classified as a Keratome, Ac-powered (Class I - General Controls, product code HNO).
Submitted by Allergan, Inc. (Santa Ana, US). The FDA issued a Cleared decision on December 15, 1986, 56 days after receiving the submission on October 20, 1986.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4370.
| 510(k) Number | K864065 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 20, 1986 |
| Decision Date | December 15, 1986 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HNO — Keratome, Ac-powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.4370 |