DISPOSABLE VITRECTOMY LENS

Lens, Contact, Polymethylmethacrylate, Diagnostic

OCULAR INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Ocular Instruments, Inc. with the FDA for Disposable Vitrectomy Lens.

Pre-market Notification Details

Device IDK012096
510k NumberK012096
Device Name:DISPOSABLE VITRECTOMY LENS
ClassificationLens, Contact, Polymethylmethacrylate, Diagnostic
Applicant OCULAR INSTRUMENTS, INC. 2255 116TH AVE., N.E. Bellevue,  WA  98004 -3039
ContactRaymond Graham
CorrespondentRaymond Graham
OCULAR INSTRUMENTS, INC. 2255 116TH AVE., N.E. Bellevue,  WA  98004 -3039
Product CodeHJK  
CFR Regulation Number886.1385 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-07-05
Decision Date2001-08-24

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00630238118132 K012096 000
00630238090001 K012096 000
00630238090018 K012096 000
00630238090025 K012096 000
00630238090032 K012096 000
00630238075206 K012096 000
00630238075213 K012096 000
00630238075220 K012096 000
00630238075237 K012096 000
00630238075244 K012096 000
00630238117500 K012096 000
00630238089982 K012096 000

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