O-PERM 30 A RIGID GAS PERMEABLE CONTACT LENS

Lens, Contact (other Material) - Daily

OPTICAL POLYMER RESEARCH, INC.

The following data is part of a premarket notification filed by Optical Polymer Research, Inc. with the FDA for O-perm 30 A Rigid Gas Permeable Contact Lens.

Pre-market Notification Details

Device IDK954124
510k NumberK954124
Device Name:O-PERM 30 A RIGID GAS PERMEABLE CONTACT LENS
ClassificationLens, Contact (other Material) - Daily
Applicant OPTICAL POLYMER RESEARCH, INC. 235 NORTH TALBOT CT. Roswell,  GA  30076 -2480
ContactWally Stirling
CorrespondentWally Stirling
OPTICAL POLYMER RESEARCH, INC. 235 NORTH TALBOT CT. Roswell,  GA  30076 -2480
Product CodeHQD  
CFR Regulation Number886.5916 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-09-01
Decision Date1996-03-19
Summary:summary

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