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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 K860703
Device Name U - STAR (MICRO-STAR)
Applicant
Corning Costar Corp.
205 Broadway
Cambridge,  MA  02139
Applicant Contact PETER C SUTCLIFFE
Correspondent
Corning Costar Corp.
205 Broadway
Cambridge,  MA  02139
Correspondent Contact PETER C SUTCLIFFE
Regulation Number880.5440
Classification Product Code
LHI  
Date Received02/26/1986
Decision Date 05/06/1986
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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