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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gastrointestinal Tubes With Enteral Specific Connectors
510(k) Number K190414
Device Name Moss Gastrostomy Tube, Moss Nasal Tube – Mark IV
Applicant
Moss Tubes, Inc.
1929 Route 9
Castleton on Hudson,  NY  12033
Applicant Contact Michael Moss
Correspondent
Xeridiem Medical Devices
4700 South Overland Drive
Tucson,  AZ  85714
Correspondent Contact Meghan McGovern
Regulation Number876.5980
Classification Product Code
PIF  
Subsequent Product Codes
BSS   KNT  
Date Received02/21/2019
Decision Date 06/14/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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