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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 K880242
Device Name KONE CALCIUM TEST
Applicant
The Rupp & Bowman Co.
9206 Royal Ln.
Irving,  TX  75063
Applicant Contact SAMIR SHAMMAS
Correspondent
The Rupp & Bowman Co.
9206 Royal Ln.
Irving,  TX  75063
Correspondent Contact SAMIR SHAMMAS
Regulation Number862.1145
Classification Product Code
CJY  
Date Received01/20/1988
Decision Date 03/15/1988
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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