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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wound Drain Catheter System
510(k) Number K203394
Device Name PleuraFlow System with FlowGlide
Applicant
Clearflow, Inc.
140 Technology Dr. Suite 100
Irvine,  CA  92618
Applicant Contact Serrah Namini
Correspondent
Clearflow, Inc.
140 Technology Dr. Suite 100
Irvine,  CA  92618
Correspondent Contact Serrah Namini
Regulation Number878.4780
Classification Product Code
OTK  
Subsequent Product Code
GBX  
Date Received11/18/2020
Decision Date 03/02/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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