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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 K991847
Device Name THERMOFLEX SYSTEM
Applicant
ARGOMED, INC.
3800 GATEWAY CENTER BLVD.
MORRISVILLE,  NC  27560
Applicant Contact RICHARD B KLEIN
Correspondent
ARGOMED, INC.
3800 GATEWAY CENTER BLVD.
MORRISVILLE,  NC  27560
Correspondent Contact RICHARD B KLEIN
Regulation Number876.4300
Classification Product Code
KNS  
Subsequent Product Codes
GEX   KOE  
Date Received05/28/1999
Decision Date 08/26/1999
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
Predetermined Change
Control Plan Authorized		 No
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