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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Implantable
510(k) Number K190884
Device Name TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool
Applicant
Datascope Corp.
15 Law Dr.
Fairfield,  NJ  07004
Applicant Contact Mark Dinger
Correspondent
Datascope Corp.
15 Law Dr.
Fairfield,  NJ  07004
Correspondent Contact Mark Dinger
Regulation Number878.4750
Classification Product Code
GDW  
Subsequent Product Code
FTL  
Date Received04/04/2019
Decision Date 12/26/2019
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
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