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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name speculum, vaginal, nonmetal
510(k) Number K951528
Device Name AMSINO DISPOSABLE VIGINAL SPECULUM
Applicant
AMSINO INTL., INC.
222 SOUTH FIFTH AVE.
CITY OF INDUSTRY,  CA  91746 -2900
Applicant Contact RICHARD Y LI
Correspondent
AMSINO INTL., INC.
222 SOUTH FIFTH AVE.
CITY OF INDUSTRY,  CA  91746 -2900
Correspondent Contact RICHARD Y LI
Regulation Number884.4530
Classification Product Code
HIB  
Date Received04/03/1995
Decision Date 05/11/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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