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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 Dr.
Irvine,  CA  92623 -9534
Applicant Contact Emily Huang
Correspondent
Allergan, Inc.
2525 Dupont Dr.
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
Predetermined Change
Control Plan Authorized		 No
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