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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name tube, feeding
510(k) Number K897181
Device Name L.T.C. PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE
Applicant
INTL. MEDICAL MARKETING, INC.
P.O. BOX 578
RIDGE,  NY  11961
Applicant Contact RAMON MONAST
Correspondent
INTL. MEDICAL MARKETING, INC.
P.O. BOX 578
RIDGE,  NY  11961
Correspondent Contact RAMON MONAST
Regulation Number876.5980
Classification Product Code
FPD  
Date Received12/28/1989
Decision Date 03/27/1990
Decision Substantially Equivalent - With Drug (SESD)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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