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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 K932369
FOIA Releasable 510(k) K932369
Device Name UROPAPER EIKEN 7
Applicant
TANABE U.S.A., INC.
P.O. BOX 85132
SAN DIEGO,  CA  92186
Applicant Contact HIROSHI SUGANO
Correspondent
TANABE U.S.A., INC.
P.O. BOX 85132
SAN DIEGO,  CA  92186
Correspondent Contact HIROSHI SUGANO
Regulation Number862.1340
Classification Product Code
JIL  
Date Received04/19/1993
Decision Date 11/16/1993
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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