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510(k) K152429

Slit Lamp Microscope by Shanghai Mediworks Precision Instruments Co. , Ltd. — Product Code HJO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 2016
Date Received
August 26, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Biomicroscope, Slit-Lamp, Ac-Powered
Device Class
Class II
Regulation Number
886.1850
Review Panel
OP
Submission Type

Other clearances by Shanghai Mediworks Precision Instruments Co. , Ltd.

  • K142263 — Applanation Tonometer (April 15, 2016)
  • K100439 — MEDIWORKS SLIT LAMP (July 16, 2010)

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