Medical Devices: Ophthalmic Devices; Classification of the Eyelid Thermal Pulsation System

Document ID: FDA-2011-M-0570-0001
Document Type: Rule
Agency: Food And Drug Administration
Topics: No Topics associated with this document
Federal Register Number: 2011-21195
CFR Citation: 21 CFR Part 886
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Details Information

Document Subtype: Final Rule
Received Date: August 19 2011, at 12:00 AM Eastern Daylight Time
Start-End Page: 51876 - 51878
Page Count: 3

Attachments:

Reference 1 - Request for Evaluation of Automiatic Class III LipiFlow® Thermal Pulsation Sysytem Premarket Notification No. K093937 Date of NSE Decision: July 12, 2010 -TearScience De novo cover letter 08062010

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