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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 K882089
Device Name MRM GASTROSTOMY BELT
Applicant
Mrm Products, Inc.
10 Piney Branch Rd.
Cranbury,  NJ  08512
Applicant Contact MARIE MARUT
Correspondent
Mrm Products, Inc.
10 Piney Branch Rd.
Cranbury,  NJ  08512
Correspondent Contact MARIE MARUT
Regulation Number876.5980
Classification Product Code
KNT  
Date Received05/19/1988
Decision Date 09/13/1988
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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