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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, I.V. Fluid Transfer
510(k) Number K980381
Device Name PHASEAL, CLOSED SYSTEM FORHANDLING OF PARENTERAL DRUGS, ADDITIONAL ADMINISTRATION DEVICES. C80 INFUSION ADAPTER, A10 PRO
Applicant
Carmel Pharma Ab.
Box 5352
Gothenburg,  SE 40228
Applicant Contact BRITT NOVEN
Correspondent
Carmel Pharma Ab.
Box 5352
Gothenburg,  SE 40228
Correspondent Contact BRITT NOVEN
Regulation Number880.5440
Classification Product Code
LHI  
Date Received02/02/1998
Decision Date 03/03/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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