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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Double Lumen For Intestinal Decompression And/Or Intubation
510(k) Number K040388
Device Name NEXT GENERATION SALEM SUMP
Applicant
Kendall
15 Hampshire St.
Mansfield,  MA  02048
Applicant Contact JIM WELSH
Correspondent
Kendall
15 Hampshire St.
Mansfield,  MA  02048
Correspondent Contact JIM WELSH
Regulation Number876.5980
Classification Product Code
FEG  
Date Received02/17/2004
Decision Date 05/17/2004
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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