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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Diagnostic
510(k) Number K903199
Device Name HOLLOW LUMEN NEEDLE, PART NUMBER: MX920
Applicant
Medex, Inc.
6250 Shier Rings Rd.
Dublin,  OH  40316
Applicant Contact CATHY CHENETSKI
Correspondent
Medex, Inc.
6250 Shier Rings Rd.
Dublin,  OH  40316
Correspondent Contact CATHY CHENETSKI
Regulation Number870.1200
Classification Product Code
DQO  
Date Received07/20/1990
Decision Date 12/17/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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