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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Gastro-Enterostomy
510(k) Number K903086
Device Name TUBE GASTROSTOMY
Applicant
Knight Medical, Inc.
320 Charles St.
Cambridge,  MA  02141
Applicant Contact LEN COOKE
Correspondent
Knight Medical, Inc.
320 Charles St.
Cambridge,  MA  02141
Correspondent Contact LEN COOKE
Regulation Number876.5980
Classification Product Code
KGC  
Date Received07/12/1990
Decision Date 11/20/1990
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
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