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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Case, Contact Lens
510(k) Number K140488
Device Name CONTACT LENS CASE
Applicant
Maca Plastics, Inc.
3455 Cross Rd.
Winchester,  OH  45697
Applicant Contact CORRINA CULBERTSON
Correspondent
Maca Plastics, Inc.
3455 Cross Rd.
Winchester,  OH  45697
Correspondent Contact CORRINA CULBERTSON
Regulation Number886.5928
Classification Product Code
LRX  
Date Received02/27/2014
Decision Date 09/10/2014
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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