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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Angiographic
510(k) Number K941979
Device Name VIDEO PLUS WITH ANALYTICAL WORKSTATION
Applicant
Camtronics, Ltd.
900 Walnut Ridge Dr.
P.O. Box 950
Hartland,  WI  53029
Applicant Contact ROBERT KRIEDERMANN
Correspondent
Camtronics, Ltd.
900 Walnut Ridge Dr.
P.O. Box 950
Hartland,  WI  53029
Correspondent Contact ROBERT KRIEDERMANN
Regulation Number892.1600
Classification Product Code
IZI  
Date Received04/25/1994
Decision Date 08/17/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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