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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 K200747
Device Name PuriLens Plus Preservative Free Saline
Applicant
The Lifestyle Company, Inc.
6 Paragon Way Suite 112
Freehold,  NJ  07728
Applicant Contact Tom Seidner
Correspondent
Emergo Global Consulting, LLC
2500 Bee Cave Rd.
Bldg. 1, Suite 300
Austin,  TX  78746
Correspondent Contact Michael A. Siano
Regulation Number886.5928
Classification Product Code
LPN  
Subsequent Product Code
MRC  
Date Received03/23/2020
Decision Date 05/15/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
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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