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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilator, non-continuous (respirator)
510(k) Number K041035
Device Name HOFFRICHTER TREND 110 CPAP DEVICE WITH AQUATREND III CPAP HUMIDIFIER ACCESSORY FOR TREND
Applicant
HOFFRICHTER GMBH
S65 W35739 PIPER RD.
EAGLE,  WI  53119
Applicant Contact STEPHEN GORSKI
Correspondent
HOFFRICHTER GMBH
S65 W35739 PIPER RD.
EAGLE,  WI  53119
Correspondent Contact STEPHEN GORSKI
Regulation Number868.5905
Classification Product Code
BZD  
Date Received04/21/2004
Decision Date 06/09/2004
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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