SubQKath Catheter And Needle Set

Catheter, Conduction, Anesthetic

HK Surgical

The following data is part of a premarket notification filed by Hk Surgical with the FDA for Subqkath Catheter And Needle Set.

Pre-market Notification Details

Device IDK193664
510k NumberK193664
Device Name:SubQKath Catheter And Needle Set
ClassificationCatheter, Conduction, Anesthetic
Applicant HK Surgical 1271 Puerto Del Sol San Clemente,  CA  92673
ContactGary Mocnik
CorrespondentGary Mocnik
HK Surgical 1271 Puerto Del Sol San Clemente,  CA  92673
Product CodeBSO  
CFR Regulation Number868.5120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-31
Decision Date2020-09-09

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