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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K163102
Device Name ReliaCatch Specimen Retrieval Bag 10mm; ReliaCatch Specimen Retrieval Bag 12mm
Applicant
Covidien
60 Middleton Ave.
North Haven,  CT  06473
Applicant Contact KATIE BROWN
Correspondent
Covidien
60 Middleton Ave.
North Haven,  CT  06473
Correspondent Contact KATIE BROWN
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received11/07/2016
Decision Date 11/30/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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