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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 K031492
Device Name MOSSMED DUAL INTERMITTENT ASPIRATOR
Applicant
Moss Medical Products
4049 Ny 150
West Sand Lake,  NY  12196
Applicant Contact GERALD MOSS
Correspondent
Moss Medical Products
4049 Ny 150
West Sand Lake,  NY  12196
Correspondent Contact GERALD MOSS
Regulation Number876.5980
Classification Product Code
KNT  
Date Received05/12/2003
Decision Date 02/05/2004
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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