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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 K053486
Device Name TREND 200 CPAP DEVICE, MODEL 5CP201; TRENDSET PC SOFTWARE, MODEL TRENDSET
Applicant
Hoffrichter GmbH
S65w35739 Piper Rd.
Egale,  WI  53119
Applicant Contact STEPHEN H GORSKI
Correspondent
Hoffrichter GmbH
S65w35739 Piper Rd.
Egale,  WI  53119
Correspondent Contact STEPHEN H GORSKI
Regulation Number868.5905
Classification Product Code
BZD  
Date Received12/15/2005
Decision Date 01/04/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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