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510(k) K173108

Smoklean by Sejong Medical Co., Ltd. — Product Code FYD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 2018
Date Received
September 29, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Exhaust, Surgical
Device Class
Class II
Regulation Number
878.5070
Review Panel
HO
Submission Type

Other clearances by Sejong Medical Co., Ltd.

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  • K173112 — LAP-iX (November 21, 2017)
  • K171726 — LapBag (September 25, 2017)
  • K171741 — Laport (August 29, 2017)

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