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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 K854365
Device Name IV SETS WITH NO PHTHALATE PLASTICIZER COMPONENTS
Applicant
Migada, Ltd.
Medical Equipment Industrial
Science Based Ind. Park
P.O. B. 211 Rehovot 76101,  IL
Applicant Contact DAVID THALER
Correspondent
Migada, Ltd.
Medical Equipment Industrial
Science Based Ind. Park
P.O. B. 211 Rehovot 76101,  IL
Correspondent Contact DAVID THALER
Regulation Number880.5440
Classification Product Code
FPA  
Date Received10/29/1985
Decision Date 03/24/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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