REFRESH RELIEVA For CONTACTS

Accessories, Soft Lens Products

Allergan, Inc

The following data is part of a premarket notification filed by Allergan, Inc with the FDA for Refresh Relieva For Contacts.

Pre-market Notification Details

Device IDK190674
510k NumberK190674
Device Name:REFRESH RELIEVA For CONTACTS
ClassificationAccessories, Soft Lens Products
Applicant Allergan, Inc 2525 Dupont Drive Irvine,  CA  92623 -9534
ContactEmily Huang
CorrespondentEmily Huang
Allergan, Inc 2525 Dupont Drive Irvine,  CA  92623 -9534
Product CodeLPN  
CFR Regulation Number886.5928 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-03-15
Decision Date2019-08-08

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00300236632083 K190674 000

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