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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 K951489
Device Name MRI'S ALL SILICONE GASTROSTOMY TUBE
Applicant
Manufacturing & Research, Inc.
P.O. Box 2308
1247 Florida Ave.
Palm Harbor,  FL  34682
Applicant Contact PATRICK J LAMB
Correspondent
Manufacturing & Research, Inc.
P.O. Box 2308
1247 Florida Ave.
Palm Harbor,  FL  34682
Correspondent Contact PATRICK J LAMB
Regulation Number876.5980
Classification Product Code
KNT  
Date Received03/31/1995
Decision Date 06/07/1995
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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