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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 K901428
Device Name DISPOSABLE GASTROINTESTINAL POLYPECTOMY SNARE
Applicant
TELEMED SYSTEMS, INC.
8 KANE INDUSTRIAL DR.
HUDSON,  MA  01749
Applicant Contact JOHN A CHAVES
Correspondent
TELEMED SYSTEMS, INC.
8 KANE INDUSTRIAL DR.
HUDSON,  MA  01749
Correspondent Contact JOHN A CHAVES
Regulation Number876.4300
Classification Product Code
FDI  
Date Received03/26/1990
Decision Date 06/18/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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