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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 K153681
Device Name PleuraFlow System
Applicant
Clearflow, Inc.
S. Sunkist St., Suite E
Anaheim,  CA  92806
Applicant Contact DOV GAL
Correspondent
Clearflow, Inc.
S. Sunkist St., Suite E
Anaheim,  CA  92806
Correspondent Contact DOV GAL
Regulation Number878.4780
Classification Product Code
OTK  
Subsequent Product Code
GBX  
Date Received12/22/2015
Decision Date 01/20/2016
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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