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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
Other 510(k) Applications for this Contact
Regulation Number
886.1120
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Classification Product Code
HKI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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