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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, Bronchoscope (Non-Rigid)
510(k) Number K930419
Device Name WILTEK BIOPSY FORCEPS
Applicant
Wiltek Medical, Inc.
P.O.Box 11946
Winston-Salem,  NC  27116
Applicant Contact JON S WILSON
Correspondent
Wiltek Medical, Inc.
P.O.Box 11946
Winston-Salem,  NC  27116
Correspondent Contact JON S WILSON
Regulation Number874.4680
Classification Product Code
BWH  
Date Received01/26/1993
Decision Date 06/01/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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