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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name phosphomolybdate (colorimetric), inorganic phosphorus
510(k) Number K991867
Device Name INORGANIC PHOSPHORUS (IP), PRODUCT NO'S, 112-01, 112-02
Applicant
A.P. TOTAL CARE, INC.
70 HAWLEY AVE,
PO BOX 6216
BRIDGEPORT,  CT 
Applicant Contact LUIS P LEON
Correspondent
A.P. TOTAL CARE, INC.
70 HAWLEY AVE,
PO BOX 6216
BRIDGEPORT,  CT 
Correspondent Contact LUIS P LEON
Regulation Number862.1580
Classification Product Code
CEO  
Date Received06/01/1999
Decision Date 08/02/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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