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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spatula, Cervical, Cytological
510(k) Number K963685
Device Name EOS BRAND DISPOSABLE CYTO/CERVICAL SAMPLER
Applicant
NORTH EOS INDUSTRIES, INC.
54, LANE 1, BEEN ST.
P.O. BOX 22, TUNG SHIH
TAICHUNG HSIEN 423,  TW
Applicant Contact SARA CHEN
Correspondent
NORTH EOS INDUSTRIES, INC.
54, LANE 1, BEEN ST.
P.O. BOX 22, TUNG SHIH
TAICHUNG HSIEN 423,  TW
Correspondent Contact SARA CHEN
Regulation Number884.4530
Classification Product Code
HHT  
Date Received09/03/1996
Decision Date 10/11/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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