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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 K860322
Device Name CLINISET INFUSION SET
Applicant
Zimmar Consulting , Ltd.
1801 Mcgill College Ave.,
Suite 1470
Montreal, Canada H3a2n4,  CA
Applicant Contact DOUGLAS M BENNETT
Correspondent
Zimmar Consulting , Ltd.
1801 Mcgill College Ave.,
Suite 1470
Montreal, Canada H3a2n4,  CA
Correspondent Contact DOUGLAS M BENNETT
Regulation Number880.5440
Classification Product Code
FPA  
Date Received01/29/1986
Decision Date 04/07/1986
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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