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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name vaporizer, anesthesia, non-heated
510(k) Number K973051
Device Name DRAGER-VAPOR 19.1 W/PLUG SYSTEM S PLUS
Applicant
DRAEGER MEDICAL, INC.
3135 QUARRY RD.
TELFORD,  PA  18969
Applicant Contact JAMES J BRENNAN
Correspondent
DRAEGER MEDICAL, INC.
3135 QUARRY RD.
TELFORD,  PA  18969
Correspondent Contact JAMES J BRENNAN
Regulation Number868.5880
Classification Product Code
CAD  
Date Received08/15/1997
Decision Date 10/30/1997
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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