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510(k) K152535

Z5 Slit lamp microscope, Z2 Slit lamp microscope by Takagi Seiko Co., Ltd. — Product Code HJO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 2016
Date Received
September 4, 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 Takagi Seiko Co., Ltd.

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  • K063352 — ELLEX SLIT LAMP, MODEL 30XL (March 13, 2007)

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  • K170470 — Digital Eye Anterior Camera (October 6, 2017)
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  • K162684 — SL 220 (May 31, 2017)
  • K163564 — SLIT LAMP SL-2000 (May 19, 2017)