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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Conduction, Anesthetic
510(k) Number K193664
Device Name SubQKath Catheter and Needle Set
Applicant
HK Surgical
1271 Puerto del Sol
San Clemente,  CA  92673
Applicant Contact Gary Mocnik
Correspondent
HK Surgical
1271 Puerto del Sol
San Clemente,  CA  92673
Correspondent Contact Gary Mocnik
Regulation Number868.5120
Classification Product Code
BSO  
Date Received12/31/2019
Decision Date 09/09/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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