INTRA ORAL CAMERA SYSTEM & ACCESSORIES, MODEL WIN-100D

Unit, Operative Dental

WIN-US TECHNOLOGY CO., LTD.

The following data is part of a premarket notification filed by Win-us Technology Co., Ltd. with the FDA for Intra Oral Camera System & Accessories, Model Win-100d.

Pre-market Notification Details

Device IDK040691
510k NumberK040691
Device Name:INTRA ORAL CAMERA SYSTEM & ACCESSORIES, MODEL WIN-100D
ClassificationUnit, Operative Dental
Applicant WIN-US TECHNOLOGY CO., LTD. 1308 MORNINGSIDE PARK DRIVE Alpharetta,  GA  30022
ContactJay Mansour
Product CodeEIA  
CFR Regulation Number872.6640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2004-03-17
Decision Date2004-03-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
EKAV101149960 K040691 000
EKAV101149840 K040691 000
EKAV100719700 K040691 000
EKAV100719690 K040691 000
EKAV100713330 K040691 000
EKAV082243310 K040691 000
EKAV101289070 K040691 000
EKAV101289030 K040691 000

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