AMSINO DISPOSABLE VIGINAL SPECULUM

Speculum, Vaginal, Nonmetal

AMSINO INTL., INC.

The following data is part of a premarket notification filed by Amsino Intl., Inc. with the FDA for Amsino Disposable Viginal Speculum.

Pre-market Notification Details

Device IDK951528
510k NumberK951528
Device Name:AMSINO DISPOSABLE VIGINAL SPECULUM
ClassificationSpeculum, Vaginal, Nonmetal
Applicant AMSINO INTL., INC. 222 SOUTH FIFTH AVE. City Of Industry,  CA  91746 -2900
ContactRichard Y Li
CorrespondentRichard Y Li
AMSINO INTL., INC. 222 SOUTH FIFTH AVE. City Of Industry,  CA  91746 -2900
Product CodeHIB  
CFR Regulation Number884.4530 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-04-03
Decision Date1995-05-11

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