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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 K861323
Device Name REPLACEMENT GASTROSTOMY TUBE
Applicant
Microvasive
31 Maple St.
Milford,  MA  01757
Applicant Contact SAMUEL D WADE
Correspondent
Microvasive
31 Maple St.
Milford,  MA  01757
Correspondent Contact SAMUEL D WADE
Regulation Number876.5980
Classification Product Code
KNT  
Date Received04/08/1986
Decision Date 12/16/1986
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
Recalls CDRH Recalls
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