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FDA 510(k) Application Details - K061330
Device Classification Name
Biomicroscope, Slit-Lamp, Ac-Powered
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510(K) Number
K061330
Device Name
Biomicroscope, Slit-Lamp, Ac-Powered
Applicant
REICHERT, INC.
3374 WALDEN AVE.
DEPEW, NY 14043 US
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Contact
SANDRA BROWN
Other 510(k) Applications for this Contact
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
05/12/2006
Decision Date
05/25/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Statement
Type
Abbreviated
Reviewed By Third Party
Y
Expedited Review
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