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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K990288
Device Name FREE FLOW SAFETY DEVICE, MODEL MG 245052
Applicant
Teva Medical, Ltd.
482 Hudson Ter.
Englewood Cliffs,  NJ  07632
Applicant Contact MARYANN MELUS
Correspondent
Teva Medical, Ltd.
482 Hudson Ter.
Englewood Cliffs,  NJ  07632
Correspondent Contact MARYANN MELUS
Regulation Number880.5440
Classification Product Code
FPA  
Date Received01/29/1999
Decision Date 02/24/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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