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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 K950780
Device Name AMSINO CERVICAL SCRAPER
Applicant
Amsino Intl., Inc.
222 S. Fifth Ave.,
City Of Industry,  CA  91746 -2900
Applicant Contact RICHARD Y LI
Correspondent
Amsino Intl., Inc.
222 S. Fifth Ave.,
City Of Industry,  CA  91746 -2900
Correspondent Contact RICHARD Y LI
Regulation Number884.4530
Classification Product Code
HHT  
Date Received02/21/1995
Decision Date 07/25/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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