S-42 UV, T-42 UV TORIC AND M-42 UV MULTIFOCAL (HEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR

Lenses, Soft Contact, Daily Wear

OPTICAL CONNECTION, INC.

The following data is part of a premarket notification filed by Optical Connection, Inc. with the FDA for S-42 Uv, T-42 Uv Toric And M-42 Uv Multifocal (hefilcon A) Soft (hydrophilic) Contact Lens For Daily Wear.

Pre-market Notification Details

Device IDK040900
510k NumberK040900
Device Name:S-42 UV, T-42 UV TORIC AND M-42 UV MULTIFOCAL (HEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
ClassificationLenses, Soft Contact, Daily Wear
Applicant OPTICAL CONNECTION, INC. 2091 UPPER SCENIC DRIVE Felton,  CA  95018
ContactGarold L Edwards
CorrespondentGarold L Edwards
OPTICAL CONNECTION, INC. 2091 UPPER SCENIC DRIVE Felton,  CA  95018
Product CodeLPL  
CFR Regulation Number886.5925 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-04-06
Decision Date2004-06-15
Summary:summary

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