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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
510(k) Number K953661
Device Name FIRST CHOICE GLUCOSE URINE TEST STRIPS
Applicant
Polymer Technology Intl.
1871 NW Gilman Blvd.
Issaquah,  WA  98027
Applicant Contact ESTELA FIGUEROA
Correspondent
Polymer Technology Intl.
1871 NW Gilman Blvd.
Issaquah,  WA  98027
Correspondent Contact ESTELA FIGUEROA
Regulation Number862.1340
Classification Product Code
JIL  
Date Received08/07/1995
Decision Date 06/14/1996
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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