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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Nephrostomy
510(k) Number K943893
Device Name PERCUTANEOUS GRAINAGE CATHETER
Applicant
Menlo Care, Inc.
1350 Willow Rd.
Menlo Park,  CA  94025
Applicant Contact BOB BLEY
Correspondent
Menlo Care, Inc.
1350 Willow Rd.
Menlo Park,  CA  94025
Correspondent Contact BOB BLEY
Classification Product Code
LJE  
Date Received08/09/1994
Decision Date 03/07/1995
Decision Substantially Equivalent (SESE)
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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