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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name clip, implantable
510(k) Number K202124
Device Name Aesculap PAS-Port Proximal Anastomosis System
Applicant
Aesculap Inc.
3773 Corporate Parkway
Center Valley,  PA  18034
Applicant Contact Sierra Mertz
Correspondent
Aesculap Inc.
3773 Corporate Parkway
Center Valley,  PA  18034
Correspondent Contact Sierra Mertz
Regulation Number878.4300
Classification Product Code
FZP  
Date Received07/31/2020
Decision Date 09/02/2020
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
Recalls CDRH Recalls
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