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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 K945993
Device Name VAPOFIL
Applicant
SOUTHMEDIC, INC.
P.O. BOX 1365
BARRIE, ONTARIO CANADA,  CA L4M 5R4
Applicant Contact LEE MCDONALD
Correspondent
SOUTHMEDIC, INC.
P.O. BOX 1365
BARRIE, ONTARIO CANADA,  CA L4M 5R4
Correspondent Contact LEE MCDONALD
Regulation Number868.5880
Classification Product Code
CAD  
Date Received11/18/1994
Decision Date 02/22/1995
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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