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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 K942545
Device Name SIGMA ELITE
Applicant
PENLON LTD.
ABINGDON OX 14 3PH
ABINGDON OX,  GB
Applicant Contact A. C GREEN
Correspondent
PENLON LTD.
ABINGDON OX 14 3PH
ABINGDON OX,  GB
Correspondent Contact A. C GREEN
Regulation Number868.5880
Classification Product Code
CAD  
Date Received05/31/1994
Decision Date 02/03/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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