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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 K221003
Device Name Autosuture EEA Stapler / circular stapler with DST Series Technology / EEA Autosuture Circular Stapler with DST Series Technology / DST Series EEA Stapler / DST EEA
60 Middletown Avenue
North Haven,  CT  06473
Applicant Contact Sanja Jahr
60 Middletown Avenue
North Haven,  CT  06473
Correspondent Contact Sanja Jahr
Regulation Number878.4750
Classification Product Code
Subsequent Product Code
Date Received04/05/2022
Decision Date 09/30/2022
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