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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 K901151
Device Name I.V. ADMINISTRATION SET CONNECTING DEVICE
Applicant
Dmd, Div. of Casta Pacific Co.
10770 Banner Mine Way
Nevada City,  CA  95959
Applicant Contact JOHN T WRIGHT
Correspondent
Dmd, Div. of Casta Pacific Co.
10770 Banner Mine Way
Nevada City,  CA  95959
Correspondent Contact JOHN T WRIGHT
Regulation Number880.5440
Classification Product Code
FPA  
Date Received03/12/1990
Decision Date 07/02/1990
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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