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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 N. Chestnut St. #300
Winston-Salem,  NC  27101
Applicant Contact JON S WILSON
Correspondent
Wiltek Medical, Inc.
101 N. 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
Predetermined Change
Control Plan Authorized		 No
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