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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name connector, airway (extension)
510(k) Number K863318
Device Name AEROSOL-T
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 Number868.5810
Classification Product Code
BZA  
Date Received08/26/1986
Decision Date 09/11/1986
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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