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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gas-Machine, Anesthesia
510(k) Number K041622
Device Name MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM
Applicant
Draeger Medical, Inc.
3135 Quarry Rd.
Telford,  PA  18969
Applicant Contact MICHAEL A KELHART
Correspondent
Draeger Medical, Inc.
3135 Quarry Rd.
Telford,  PA  18969
Correspondent Contact MICHAEL A KELHART
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received06/16/2004
Decision Date 07/08/2004
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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