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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name nebulizer (direct patient interface)
510(k) Number K072136
Device Name ULTRASONIC NEBULISER MODEL 2010
Applicant
WILFRED KROMKER GMBH
S65 W35739 PIPER ROAD
EAGLE,  WI  53119
Applicant Contact STEPHEN GORSKI
Correspondent
WILFRED KROMKER GMBH
S65 W35739 PIPER ROAD
EAGLE,  WI  53119
Correspondent Contact STEPHEN GORSKI
Regulation Number868.5630
Classification Product Code
CAF  
Date Received08/02/2007
Decision Date 07/15/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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