FDA 510(k) Premarket Notification K133115: COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACK

Submission Details & Decision

Normalized public record details for 510(k) notification K133115.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K133115

Applicant / Sponsor

Abbott Medical Optics, Inc.

Device Name

COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACK

Product Code

HQC

Decision Date

2014-02-27

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Ophthalmic (OP)

Clearance Type

Abbreviated

Third Party Flag

Date Received

2013-09-30

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