OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER

Accessories, Soft Lens Products

ALCON LABORATORIES

The following data is part of a premarket notification filed by Alcon Laboratories with the FDA for Opti-free Supraclens Daily Protein Remover.

Pre-market Notification Details

Device IDK974625
510k NumberK974625
Device Name:OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER
ClassificationAccessories, Soft Lens Products
Applicant ALCON LABORATORIES 6201 SOUTH FREEWAY R7-14 Fort Worth,  TX  76134 -2099
ContactRalph H Larsen
CorrespondentRalph H Larsen
ALCON LABORATORIES 6201 SOUTH FREEWAY R7-14 Fort Worth,  TX  76134 -2099
Product CodeLPN  
CFR Regulation Number886.5928 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-12-11
Decision Date1998-03-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00300650285445 K974625 000

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