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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Balloon Inflation
510(k) Number K910958
Device Name MEDFLATOR INFLATION SYSTEM
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 Number870.1650
Classification Product Code
MAV  
Date Received03/06/1991
Decision Date 07/12/1991
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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