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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 K002343
Device Name SIGMA DELTA
Applicant
PENLON LTD.
Abingdon Science Park
Barton Lane, Abingdon,  GB OX14 3NB
Applicant Contact ANTHONY PARSONS
Correspondent
PENLON LTD.
Abingdon Science Park
Barton Lane, Abingdon,  GB OX14 3NB
Correspondent Contact ANTHONY PARSONS
Regulation Number868.5880
Classification Product Code
CAD  
Date Received08/01/2000
Decision Date 06/08/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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