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510(k) K172331

Type I, Type II, Type III, Type IV by Lepu Medical Technology (Beijing) Co., Ltd. — Product Code DYB

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
March 2, 2018
Date Received
August 2, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
Submission Type

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  • K111837 — RADIAL ARTERY COMPRESSION TOURNIQUET (September 27, 2011)

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