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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hemostatic Device For Endoscopic Gastrointestinal Use
510(k) Number K200972
Device Name Hemospray Endoscopic Hemostat
Applicant
Wilson-Cook Medical, Inc.
4900 Bethania Station Rd.
Winston-Salem,  NC  27105
Applicant Contact Marge Walls-Walker
Correspondent
Wilson-Cook Medical, Inc.
4900 Bethania Station Rd.
Winston-Salem,  NC  27105
Correspondent Contact Marge Walls-Walker
Regulation Number878.4456
Classification Product Code
QAU  
Date Received04/13/2020
Decision Date 06/10/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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