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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 K990231
Device Name WILTEK HOT BIOPSY FORCEPS
Applicant
WILTEK MEDICAL, INC.
101 NORTH CHESTNUT ST., #300
WINSTON-SALEM,  NC  27101
Applicant Contact JON S WILSON
Correspondent
WILTEK MEDICAL, INC.
101 NORTH CHESTNUT ST., #300
WINSTON-SALEM,  NC  27101
Correspondent Contact JON S WILSON
Regulation Number876.4300
Classification Product Code
KGE  
Date Received01/25/1999
Decision Date 04/13/1999
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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