50 DEGREE HRI PRISM 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 50 Degree Hri Prism Lens.

Pre-market Notification Details

Device IDK941420
510k NumberK941420
Device Name:50 DEGREE HRI PRISM LENS
ClassificationLens, Contact, Polymethylmethacrylate, Diagnostic
Applicant OCULAR INSTRUMENTS, INC. 2255 116TH AVE., N.E. Bellevue,  WA  98004 -3039
ContactPhillip J Erickson
CorrespondentPhillip J Erickson
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 Received1994-03-23
Decision Date1994-08-29

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00630238008655 K941420 000

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