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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Catheter And Tip, Suction
510(k) Number K913876
Device Name ENDOTRACHEAL SUCTIONTUBE
Applicant
Willowtech
P.O. Box 185789
Fort Worth,  TX  76181
Applicant Contact KEITH JUNG
Correspondent
Willowtech
P.O. Box 185789
Fort Worth,  TX  76181
Correspondent Contact KEITH JUNG
Regulation Number880.6740
Classification Product Code
JOL  
Date Received08/29/1991
Decision Date 03/06/1992
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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