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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 K942628
Device Name ESOPHAGEAL INTUBATION DETECTOR BULB
Applicant
WOLFE TORY MEDICAL, INC.
P.O. BOX 526437
SALT LAKE CITY,  UT  84152
Applicant Contact TIMOTHY R WOLFE
Correspondent
WOLFE TORY MEDICAL, INC.
P.O. BOX 526437
SALT LAKE CITY,  UT  84152
Correspondent Contact TIMOTHY R WOLFE
Regulation Number868.5730
Classification Product Code
BTR  
Date Received06/02/1994
Decision Date 08/18/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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