K082132 is an FDA 510(k) clearance for the BAUSCH & LOMB D4600A AIR EXCHANGE LINE PACK. This device is classified as a Unit, Phacofragmentation (Class II - Special Controls, product code HQC).
Submitted by Bausch & Lomb, Inc. (Rochester, US). The FDA issued a Cleared decision on August 28, 2008, 30 days after receiving the submission on July 29, 2008.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4670.
| 510(k) Number | K082132 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 29, 2008 |
| Decision Date | August 28, 2008 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HQC - Unit, Phacofragmentation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4670 |