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FDA 510(k) Application Details - K080776
Device Classification Name
Biomicroscope, Slit-Lamp, Ac-Powered
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510(K) Number
K080776
Device Name
Biomicroscope, Slit-Lamp, Ac-Powered
Applicant
USOPHTHALMIC, LLC
7255 NW 88TH STREET
UNIT 9
MIAMI, FL 33166 US
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Contact
AL WEISENBORN
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Regulation Number
886.1850
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Classification Product Code
HJO
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More FDA Info for this Product Code
Date Received
03/19/2008
Decision Date
09/09/2008
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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