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FDA 510(k) Application Details - K132987
Device Classification Name
Camera, Ophthalmic, Ac-Powered
More FDA Info for this Device
510(K) Number
K132987
Device Name
Camera, Ophthalmic, Ac-Powered
Applicant
C.S.O. S.R.L.
110 EAST GRANADA BLVD, STE 209
ORMOND BEACH, FL 32716 US
Other 510(k) Applications for this Company
Contact
Claude Berthoin
Other 510(k) Applications for this Contact
Regulation Number
886.1120
More FDA Info for this Regulation Number
Classification Product Code
HKI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/24/2013
Decision Date
07/03/2014
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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