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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
510(k) Number K992402
Device Name 5.0 FRENCH X 200CM X 35MM TIP TAPER-20MM CUTTING WIRE, 5.0 FRENCH X 200CM X 35MM TIP TAPER-30MM CUTTING WIRE, 5.0 FRENCH
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
KNS  
Subsequent Product Code
FDI  
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
Predetermined Change
Control Plan Authorized		 No
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