VENTURI PHACO PACK— 510(k) K033653
Substantially EquivalentBausch & Lomb, Inc.
FDA 510(k) clearance K033653 for VENTURI PHACO PACK, Substantially Equivalent on 2003-12-17. Applicant: Bausch & Lomb, Inc.. Device class: 2.
Clearance details
- Applicant
- Bausch & Lomb, Inc.
- Product code
- Code HQC
- Device class
- Class 2
- Regulation
- 21 CFR 886.4670
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- St. Louis, MO, US
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Adverse events under product code HQC
product code HQC- Injury
- 2,378
- Malfunction
- 8,768
- Total
- 11,146
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.