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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K212738
Device Name Amplatzer Talisman Delivery Sheath
Applicant
Abbott Medical
177 E. County Rd. B
St.Paul,  MN  55117
Applicant Contact Daniel Gapp
Correspondent
Abbott Medical
177 E. County Rd. B
St.Paul,  MN  55117
Correspondent Contact Daniel Gapp
Regulation Number870.1250
Classification Product Code
DQY  
Date Received08/30/2021
Decision Date 09/27/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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