Submission Details
| 510(k) Number | K073023 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 26, 2007 |
| Decision Date | March 12, 2008 |
| Days to Decision | 138 days |
| Submission Type | Special |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Special
STERILS SINGLE-USE I/A HANDPIECES
Mar 2008
Decision
138d
Days
Class 2
Risk
About This 510(k) Submission
K073023 is an FDA 510(k) clearance for the STERILS SINGLE-USE I/A HANDPIECES, a Unit, Phacofragmentation (Class II — Special Controls, product code HQC), submitted by Bausch & Lomb, Inc. (Rochester, US). The FDA issued a Cleared decision on March 12, 2008, 138 days after receiving the submission on October 26, 2007. 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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