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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name mask, oxygen
510(k) Number K892434
Device Name KENDALL CURITY OXYGEN MASK
Applicant
THE KENDAL CO.
ONE FEDERAL ST.
BOSTON,  MA  02110 -2003
Applicant Contact WILLIAM D CURTIN
Correspondent
THE KENDAL CO.
ONE FEDERAL ST.
BOSTON,  MA  02110 -2003
Correspondent Contact WILLIAM D CURTIN
Regulation Number868.5580
Classification Product Code
BYG  
Date Received04/10/1989
Decision Date 08/15/1989
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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