SEBESTYEN IRRIGATING CONTACT LENS

Lens, Fundus, Hruby, Diagnostic

COOPER MEDICAL DEVICES CORP.

The following data is part of a premarket notification filed by Cooper Medical Devices Corp. with the FDA for Sebestyen Irrigating Contact Lens.

Pre-market Notification Details

Device IDK802927
510k NumberK802927
Device Name:SEBESTYEN IRRIGATING CONTACT LENS
ClassificationLens, Fundus, Hruby, Diagnostic
Applicant COOPER MEDICAL DEVICES CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeHJI  
CFR Regulation Number886.1395 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-11-19
Decision Date1981-02-05

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