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510(k) K151394

Keeler Slit Lamp by Keeler Limited — Product Code HJO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 2015
Date Received
May 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

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  • K140450 — KEELER KAPTURE SOFTWARE (June 17, 2014)
  • K133234 — T-TYPE D-KAT, R-TYPE D-KAT (February 21, 2014)

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