FRAME, SPECTACLE

Frame, Spectacle

SWANK PLUS LTD.

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

Pre-market Notification Details

Device IDK873965
510k NumberK873965
Device Name:FRAME, SPECTACLE
ClassificationFrame, Spectacle
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 CodeHQZ  
CFR Regulation Number886.5842 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-09-29
Decision Date1988-04-01

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