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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 K083684
Device Name ENDO VIVE STANDARD REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX
Applicant
MANUFACTURING & RESEARCH, INC.
4700 SOUTH OVERLAND DR.
TUCSON,  AZ  85745
Applicant Contact SUZANNE DEW
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Regulation Number876.5980
Classification Product Code
KNT  
Date Received12/12/2008
Decision Date 02/05/2009
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
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