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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Gastrointestinal (And Accessories)
510(k) Number K042572
Device Name KENDALL CO2NFIRM NOW CO2 DETECTOR
Applicant
Kendall
15 Hampshire St.
Mansfield,  MA  02048
Applicant Contact BRIDGET GARDNER
Correspondent
Kendall
15 Hampshire St.
Mansfield,  MA  02048
Correspondent Contact BRIDGET GARDNER
Regulation Number876.5980
Classification Product Code
KNT  
Date Received09/21/2004
Decision Date 11/05/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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