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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 K051206
Device Name Y2K2 ENTERNAL TUBE FLUID FILTER
Applicant
Moss Medical Products
4049 Ny 150
West Sand Lake,  NY  12196
Applicant Contact GERALD MOSS
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number876.5980
Classification Product Code
KNT  
Date Received05/11/2005
Decision Date 11/02/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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