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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plug, Punctum
510(k) Number K190210
Device Name Tear Pool Dissolvable Punctum Plugs
Applicant
Alphamed, Inc.
3912 Mountain Ave.
El Paso,  TX  79930
Applicant Contact James Gubachy
Correspondent
Alphamed, Inc.
3912 Mountain Ave.
El Paso,  TX  79930
Correspondent Contact James Gubachy
Classification Product Code
LZU  
Date Received02/04/2019
Decision Date 10/24/2019
Decision Substantially Equivalent (SESE)
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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