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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Digital Image Communications, Radiological
510(k) Number K941203
Device Name MEDICAL IMAGING WORKSTATION II (MIW II)
Applicant
Cemco, Inc.
2480 Nagawicka Rd.
Hartland,  WI  53029
Applicant Contact PHILLIP W JONES
Correspondent
Cemco, Inc.
2480 Nagawicka Rd.
Hartland,  WI  53029
Correspondent Contact PHILLIP W JONES
Regulation Number892.2020
Classification Product Code
LMD  
Date Received03/14/1994
Decision Date 06/27/1994
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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