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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector And Syringe, Angiographic
510(k) Number K935668
Device Name MEDRAD SPECTRIS MR INJECTOR
Applicant
Medrad, Inc.
P.O. Box 780, Medrad Dr.
Off Rte. 910
Indianola,  PA  15051
Applicant Contact JAN E BURTICK
Correspondent
Medrad, Inc.
P.O. Box 780, Medrad Dr.
Off Rte. 910
Indianola,  PA  15051
Correspondent Contact JAN E BURTICK
Regulation Number870.1650
Classification Product Code
DXT  
Date Received11/26/1993
Decision Date 09/25/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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