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510(k) K191512

LotusCatheter (Lotus No Balloon Catheter) by Hakki Medical Technologies, Inc. — Product Code GBM

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
May 21, 2020
Date Received
June 7, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Urethral
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Hakki Medical Technologies, Inc.

  • K101900 — HAKKI URINARY CATHETER; SIZE 14, 16, 18, 20, 22, 24, 26 FRENCH (February 7, 2011)

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