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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Contamination Prevention Sheath
510(k) Number K183171
Device Name ScopeSeal Duodenoscope Protective Device
Applicant
Gi Scientific, LLC
4601 N. Fairfax Dr., Suite 1200
Arlington,  VA  22203
Applicant Contact Scott Miller
Correspondent
Lakeshore Medical Device Consulting, LLC
128 Blye Hill Landing
Newbury,  NH  03255
Correspondent Contact Michele Lucey
Regulation Number876.1500
Classification Product Code
ODB  
Subsequent Product Code
FEI  
Date Received11/16/2018
Decision Date 10/08/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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