Submission Details
| 510(k) Number | K082132 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Special
BAUSCH & LOMB D4600A AIR EXCHANGE LINE PACK
Aug 2008
Decision
30d
Days
Class 2
Risk
About This 510(k) Submission
K082132 is an FDA 510(k) clearance for the BAUSCH & LOMB D4600A AIR EXCHANGE LINE PACK, a Unit, Phacofragmentation (Class II — Special Controls, product code HQC), submitted by Bausch & Lomb, Inc. (Rodchester, 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 review panel. Regulated under 21 CFR 886.4670.
Device Classification
| Product Code | HQC — Unit, Phacofragmentation |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 886.4670 |
Manufacturer
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