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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 STREET
ZUR- MOSHE,  IL 42810
Applicant Contact KAREL VAN GORP
Correspondent
X6D, LTD.
21 HANAFA STREET
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
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