FDA 510(k) Application Details - K040325

Device Classification Name Camera, Ophthalmic, Ac-Powered

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510(K) Number K040325
Device Name Camera, Ophthalmic, Ac-Powered
Applicant MEDIBELL MEDICAL VISION TECHNOLOGIES LTD.
MATAM HIGHT TECHNOLOGIES CTR
HAIFA 31905 IL
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Contact DAN LAOR
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Regulation Number 886.1120

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Classification Product Code HKI
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Date Received 02/10/2004
Decision Date 03/08/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee OP - Ophthalmic
Review Advisory Committee OP - Ophthalmic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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