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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
Applicant Contact WILLIAM D CURTIN
Correspondent
The Kendal Co.
One Federal St.
Boston,  MA  02110
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
Predetermined Change
Control Plan Authorized		 No
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