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FDA 510(k) Application Details - K093021
Device Classification Name
Biomicroscope, Slit-Lamp, Ac-Powered
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510(K) Number
K093021
Device Name
Biomicroscope, Slit-Lamp, Ac-Powered
Applicant
USOPTHALMIC, LLC
19526 EAST LAKE DR.
MIAMI, FL 33015-2218 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
09/29/2009
Decision Date
01/28/2010
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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