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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name accessories, soft lens products
510(k) Number K190674
Device Name REFRESH RELIEVA For CONTACTS
Applicant
Allergan, Inc
2525 Dupont Drive
Irvine,  CA  92623 -9534
Applicant Contact Emily Huang
Correspondent
Allergan, Inc
2525 Dupont Drive
Irvine,  CA  92623 -9534
Correspondent Contact Emily Huang
Regulation Number886.5928
Classification Product Code
LPN  
Subsequent Product Code
MRC  
Date Received03/15/2019
Decision Date 08/08/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Clinical Trials NCT01844388
Reviewed by Third Party No
Combination Product No
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