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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tube, tracheal (w/wo connector)
510(k) Number K021044
Device Name MADETT
Applicant
WOLFE TORY MEDICAL, INC.
79 WEST 4500 SOUTH, SUITE 16
SALT LAKE CITY,  UT  84107
Applicant Contact TIM WOLFE
Correspondent
WOLFE TORY MEDICAL, INC.
79 WEST 4500 SOUTH, SUITE 16
SALT LAKE CITY,  UT  84107
Correspondent Contact TIM WOLFE
Regulation Number868.5730
Classification Product Code
BTR  
Date Received04/01/2002
Decision Date 09/11/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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