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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 K191733
Device Name The ZIP Accessory Shuttle for PleuraFlow System
Applicant
Clearflow, Inc.
1630 S. Sunkist St. Suite E
Anaheim,  CA  92806
Applicant Contact Dov Gal
Correspondent
Clearflow, Inc.
1630 S. Sunkist St. Suite E
Anaheim,  CA  92806
Correspondent Contact Dov Gal
Regulation Number878.4780
Classification Product Code
OTK  
Subsequent Product Code
GBX  
Date Received06/28/2019
Decision Date 07/26/2019
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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