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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
510(k) Number K132042
Device Name AMB101 SYSTEM, AMBLYZ, LCG SYSTEM, XPAND
Applicant
X6d, Ltd.
21 Hanafa St.
Zur- Moshe,  IL 42810
Applicant Contact KAREL VAN GORP
Correspondent
X6d, Ltd.
21 Hanafa St.
Zur- Moshe,  IL 42810
Correspondent Contact KAREL VAN GORP
Regulation Number886.4750
Classification Product Code
HOY  
Date Received07/02/2013
Decision Date 04/28/2014
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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