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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Applicator (Laryngo-Tracheal), Topical Anesthesia
510(k) Number K002255
FOIA Releasable 510(k) K002255
Device Name LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC)
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 Number868.5170
Classification Product Code
CCT  
Date Received07/25/2000
Decision Date 09/18/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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