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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stopcock, I.V. Set
510(k) Number K982368
Device Name MANIFOLD WITH EXTENSION SET
Applicant
Interpore Cross Intl.
181 Technology Dr.
Irvine,  CA  92618
Applicant Contact LYNN M RODARTI
Correspondent
Interpore Cross Intl.
181 Technology Dr.
Irvine,  CA  92618
Correspondent Contact LYNN M RODARTI
Regulation Number880.5440
Classification Product Code
FMG  
Date Received07/07/1998
Decision Date 07/31/1998
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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