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FDA 510(k) Application Details - K030393
Device Classification Name
Device,Analysis,Anterior Segment
More FDA Info for this Device
510(K) Number
K030393
Device Name
Device,Analysis,Anterior Segment
Applicant
HAAG-STREIT HOLDING AG
7361 CALHOUN PLACE, SUITE 500
ROCKVILLE, MD 20855-2465 US
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Contact
EDUARDO MARCH
Other 510(k) Applications for this Contact
Regulation Number
886.1850
More FDA Info for this Regulation Number
Classification Product Code
MXK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/05/2003
Decision Date
09/25/2003
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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