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PubMed · 14709284

Sealed-capsule irrigation device.

Amar Agarwal·Sunita Agarwal·Athiya Agarwal·Anthony Maloof
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Abstract

We present a sealed-capsule irrigation technique and a disposable instrument that facilitate selective targeting of lens epithelial cells after phacoemulsification.

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Disposable EquipmentEquipment DesignHumansLens Capsule, CrystallineOphthalmologyPhacoemulsificationTherapeutic IrrigationJournal Article

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Amar Agarwal, Sunita Agarwal, Athiya Agarwal, Anthony Maloof. 2003. Sealed-capsule irrigation device.. https://doi.org/10.1016/j.jcrs.2003.08.030

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PubMed2006

Medical devices; reprocessed single-use devices; requirement for submission of validation data. Direct final rule.

The Food and Drug Administration (FDA or we) is amending certain classification regulations for reprocessed single-use devices (SUDs) whose exemption from premarket notification (510(k)) requirements have been terminated and other reprocessed SUDs already subject to premarket notification for which validation data, as specified under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), are necessary in a 510(k). Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule, under FDA's usual procedures for notice and comment, to provide a procedural framework to finalize the rule in the event we receive any significant adverse comment and withdraw the direct final rule. This action codifies actions taken in previous Federal Register notices in accordance with MDUFMA.

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