Premium Plus Disposable Barrier Sleeve

Dental Barriers And Sleeves

PREMIUM PLUS INTERNATIONAL LIMITED

The following data is part of a premarket notification filed by Premium Plus International Limited with the FDA for Premium Plus Disposable Barrier Sleeve.

Pre-market Notification Details

Device IDK163447
510k NumberK163447
Device Name:Premium Plus Disposable Barrier Sleeve
ClassificationDental Barriers And Sleeves
Applicant PREMIUM PLUS INTERNATIONAL LIMITED FLAT 1001 YUEN LONG TRADING CENTRE, 33 WANG YIP STREET WEST YUEN LONG N.T. Hong Kong,  CN
ContactJessica Mao
CorrespondentJessica Mao
PREMIUM PLUS INTERNATIONAL LIMITED FLAT 1001 YUEN LONG TRADING CENTRE, 33 WANG YIP STREET WEST YUEN LONG N.T. Hong Kong,  CN
Product CodePEM  
CFR Regulation Number878.4370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-12-08
Decision Date2017-06-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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