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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Access Overtube, Gastroenterology-Urology
510(k) Number K200419
Device Name Kalera Vacuum Aspiration Catheter (K-VAC)
Applicant
Kalera Medical, Inc.
13240 Evening Creek Dr. S., Suite 304
San Diego,  CA  92128
Applicant Contact Jee Shin
Correspondent
Mandell Horwitz Consultants, LLC
5 Lake Como Ct.
Greenville,  SC  29609
Correspondent Contact Diane Horwitz
Regulation Number876.1500
Classification Product Code
FED  
Date Received02/20/2020
Decision Date 05/22/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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