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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 K193137
Device Name EASYGRIP FLO-41 Precision MIS Delivery System
Applicant
Baxter Healthcare Corportation
32650 N. Wilson Road
Round Lake,  IL  60073
Applicant Contact Jeanette Licata
Correspondent
Baxter Healthcare Corportation
32650 N. Wilson Road
Round Lake,  IL  60073
Correspondent Contact Jeanette Licata
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received11/13/2019
Decision Date 01/08/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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