AMO BRAND MULTI-PURPOSE DISINFECTING SOLUTION— 510(k) K093254
Substantially EquivalentAbbott Medical Optics, Inc.
FDA 510(k) clearance K093254 for AMO BRAND MULTI-PURPOSE DISINFECTING SOLUTION, Substantially Equivalent on 2010-09-15. Applicant: Abbott Medical Optics, Inc.. Device class: 2.
Clearance details
- Applicant
- Abbott Medical Optics, Inc.
- Product code
- Code LPN
- Device class
- Class 2
- Regulation
- 21 CFR 886.5928
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Ana, CA, US
Recent devices under product code LPN
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view all- K170322 — Catalys Precision Laser System
- K160236 — Dual Pump Pack
- K151636 — AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature Pro Advance Linear (Four-Button) Foot Pedal, WHITESTAR Signature Pro (Wireless) Remote Control
- K151783 — COMPACT INTUITIV Multiple-Use Pack
- K143434 — One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series
Adverse events under product code LPN
product code LPN- Injury
- 333
- Other
- 8
- Total
- 341
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.