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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 K940896
Device Name MEDFLATOR II(TM) DISPOSABLE INFLATION DEVICE
Applicant
Medex, Inc.
3637 Lacon Rd.
Hilliard,  OH  43026
Applicant Contact CATHY CHENETSKI
Correspondent
Medex, Inc.
3637 Lacon Rd.
Hilliard,  OH  43026
Correspondent Contact CATHY CHENETSKI
Regulation Number870.1650
Classification Product Code
MAV  
Date Received02/24/1994
Decision Date 08/11/1994
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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