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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Facility Use
510(k) Number K992608
Device Name ATC OPTION FOR EVITA 2 DURA AND EVITA 4
Applicant
Drager, Inc.
3136 Quarry Rd.
Telford,  PA  18969
Applicant Contact HARALD KNEUER
Correspondent
Drager, Inc.
3136 Quarry Rd.
Telford,  PA  18969
Correspondent Contact HARALD KNEUER
Regulation Number868.5895
Classification Product Code
CBK  
Date Received08/04/1999
Decision Date 08/24/1999
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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