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510(k) K160341

Colposcope System by Xuzhou Kernel Medical Equipment Co., Ltd. — Product Code HEX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 2016
Date Received
February 8, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colposcope (And Colpomicroscope)
Device Class
Class II
Regulation Number
884.1630
Review Panel
OB
Submission Type

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Other clearances for product code HEX

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  • K182764 — Biop Digital Colposcope (November 27, 2018)
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  • K170446 — LT-300 SD Digital Video Colposcope (May 21, 2017)
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