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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 K926073
Device Name ULTRAVAC-NG(TM) NASOGASTRIC SUMP SUCTION TUBE
Applicant
Surgimark, Inc.
4706 W. Nob Hill Blvd.
Yakima,  WA  98908
Applicant Contact RICHARD J YARGER
Correspondent
Surgimark, Inc.
4706 W. Nob Hill Blvd.
Yakima,  WA  98908
Correspondent Contact RICHARD J YARGER
Regulation Number876.5980
Classification Product Code
FEG  
Date Received12/01/1992
Decision Date 05/15/1995
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
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