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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Aspirating, Flexible, Connecting
510(k) Number K922989
Device Name WILTEK IRRIGAITON/ASPIRATION TUBE SET
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 Number880.6740
Classification Product Code
BYY  
Date Received06/22/1992
Decision Date 02/15/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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