SIGHT SAVER ALL PURPOSE LENS CARRYING CASE

Lens, Contact (polymethylmethacrylate)

BAUSCH & LOMB, INC.

The following data is part of a premarket notification filed by Bausch & Lomb, Inc. with the FDA for Sight Saver All Purpose Lens Carrying Case.

Pre-market Notification Details

Device IDK852384
510k NumberK852384
Device Name:SIGHT SAVER ALL PURPOSE LENS CARRYING CASE
ClassificationLens, Contact (polymethylmethacrylate)
Applicant BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST. P.O.BOX 450 Rochester,  NY  14692
ContactGlenn A Davies
CorrespondentGlenn A Davies
BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST. P.O.BOX 450 Rochester,  NY  14692
Product CodeHPX  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-06-05
Decision Date1985-07-31

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