FREESOFT (POLYMACON) SOFT (HYDROPHILIC) ASPHERIC CONTACT LENS

Lenses, Soft Contact, Daily Wear

UNILENS CORP., USA

The following data is part of a premarket notification filed by Unilens Corp., Usa with the FDA for Freesoft (polymacon) Soft (hydrophilic) Aspheric Contact Lens.

Pre-market Notification Details

Device IDK960376
510k NumberK960376
Device Name:FREESOFT (POLYMACON) SOFT (HYDROPHILIC) ASPHERIC CONTACT LENS
ClassificationLenses, Soft Contact, Daily Wear
Applicant UNILENS CORP., USA 10431 72ND ST. NORTH P.O. BOX 2530 Largo,  FL  34647
ContactJosepha Bruno
CorrespondentJosepha Bruno
UNILENS CORP., USA 10431 72ND ST. NORTH P.O. BOX 2530 Largo,  FL  34647
Product CodeLPL  
CFR Regulation Number886.5925 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-01-26
Decision Date1996-03-28
Summary:summary

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