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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 K900328
Device Name NARKOMED 2B ANESTHESIA SYSTEM
Applicant
Draeger Medical, Inc.
148 B. Quarry Rd.
Telford,  PA  18969
Applicant Contact JAMES BRENNAN
Correspondent
Draeger Medical, Inc.
148 B. Quarry Rd.
Telford,  PA  18969
Correspondent Contact JAMES BRENNAN
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received01/23/1990
Decision Date 02/01/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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