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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Azo Dye, Calcium
510(k) Number K944255
Device Name DMA CALCIUM PLUS PROCEDURE
Applicant
Data Medical Associates, Inc.
845 Ave. G E.
Arlington,  TX  76011
Applicant Contact C H MORRIS
Correspondent
Data Medical Associates, Inc.
845 Ave. G E.
Arlington,  TX  76011
Correspondent Contact C H MORRIS
Regulation Number862.1145
Classification Product Code
CJY  
Date Received09/01/1994
Decision Date 12/06/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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