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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name forceps, biopsy, electric
510(k) Number K992390
Device Name HOT BIOPSY FORCEPS FEENESTRATED 230 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATED 160 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATD
Applicant
TELEMED SYSTEMS, INC.
19 BRIGHAM ST., UNIT 1
MARLBOROUGH,  MA  01752
Applicant Contact JOHN A CHAVES
Correspondent
TELEMED SYSTEMS, INC.
19 BRIGHAM ST., UNIT 1
MARLBOROUGH,  MA  01752
Correspondent Contact JOHN A CHAVES
Regulation Number876.4300
Classification Product Code
KGE  
Date Received07/19/1999
Decision Date 12/22/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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