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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 K990556
Device Name ESOPHAGEAL INTUBATION DETECTOR
Applicant
Wolfe Tory Medical, Inc.
79 W. 4500 S., Suite 21
Salt Lake City,  UT  84107
Applicant Contact TIM WOLFE
Correspondent
Wolfe Tory Medical, Inc.
79 W. 4500 S., Suite 21
Salt Lake City,  UT  84107
Correspondent Contact TIM WOLFE
Regulation Number868.5730
Classification Product Code
BTR  
Date Received02/22/1999
Decision Date 03/26/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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