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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 K890302
Device Name CALCIUM PLUS PROCEDURE
Applicant
Data Medical Associates, Inc.
845 Ave. G E.
Arlington,  TX  76011
Applicant Contact MARJORIE B POTTS
Correspondent
Data Medical Associates, Inc.
845 Ave. G E.
Arlington,  TX  76011
Correspondent Contact MARJORIE B POTTS
Regulation Number862.1145
Classification Product Code
CJY  
Date Received01/23/1989
Decision Date 02/27/1989
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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