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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 K880850
Device Name KEITH NASOGASTRIC SUMP TUBE W/ANTI-REFLUX VALVE
Applicant
Kmb Medical Products Co.
320 Brookes Dr., Suite 110
Hazelwood,  MO  63042
Applicant Contact C. W KEITH
Correspondent
Kmb Medical Products Co.
320 Brookes Dr., Suite 110
Hazelwood,  MO  63042
Correspondent Contact C. W KEITH
Regulation Number876.5980
Classification Product Code
FEG  
Date Received03/01/1988
Decision Date 05/26/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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