SPECTACLE, MAGNIFYING

Aid, Vision Image Intensification

SWANK PLUS LTD.

The following data is part of a premarket notification filed by Swank Plus Ltd. with the FDA for Spectacle, Magnifying.

Pre-market Notification Details

Device IDK873967
510k NumberK873967
Device Name:SPECTACLE, MAGNIFYING
ClassificationAid, Vision Image Intensification
Applicant SWANK PLUS LTD. P.O. BOX 70750 KOWLOON CENTRAL POST OFFICE Hong Kong,  HK
ContactCider Lai
CorrespondentCider Lai
SWANK PLUS LTD. P.O. BOX 70750 KOWLOON CENTRAL POST OFFICE Hong Kong,  HK
Product CodeHOT  
CFR Regulation Number886.5910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-09-29
Decision Date1988-02-26

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.