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FDA 510(k) Application Details - K111643
Device Classification Name
Laser, Ophthalmic
More FDA Info for this Device
510(K) Number
K111643
Device Name
Laser, Ophthalmic
Applicant
OPTO ELECTRONICA SA
JOAQUIM A.R. DE SOUZA ST.
1071 - JARDIM SANTA FELICIA
SAO CARLOS, SAO PAULO 13.563-330 BR
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Contact
PAULO ANEAS LICHTI
Other 510(k) Applications for this Contact
Regulation Number
886.4390
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Classification Product Code
HQF
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More FDA Info for this Product Code
Date Received
06/13/2011
Decision Date
11/03/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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