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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name snare, flexible
510(k) Number K992477
Device Name ROTOSNARE
Applicant
INSCOPE, LLC.
19526 EAST LAKE DR.
MIAMI,  FL  33015
Applicant Contact AL WEISENBORN
Correspondent
INSCOPE, LLC.
19526 EAST LAKE DR.
MIAMI,  FL  33015
Correspondent Contact AL WEISENBORN
Regulation Number876.4300
Classification Product Code
FDI  
Date Received07/26/1999
Decision Date 08/24/1999
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
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