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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 K152580
Device Name rescuenet
Applicant
ENDOCHOICE, INC.
11810 WILLS RD.
ALPHARETTA,  GA  30009
Applicant Contact DANIEL HOEFER
Correspondent
ENDOCHOICE, INC.
11810 WILLS RD.
ALPHARETTA,  GA  30009
Correspondent Contact DANIEL HOEFER
Regulation Number876.4300
Classification Product Code
FDI  
Subsequent Product Code
GCJ  
Date Received09/10/2015
Decision Date 11/03/2015
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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