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FDA 510(k) Application Details - K141954
Device Classification Name
Biomicroscope, Slit-Lamp, Ac-Powered
More FDA Info for this Device
510(K) Number
K141954
Device Name
Biomicroscope, Slit-Lamp, Ac-Powered
Applicant
REICHERT, INC.
3362 WALDEN AVE.
DEPEW, NY 14043 US
Other 510(k) Applications for this Company
Contact
THOMAS M HECKMANN
Other 510(k) Applications for this Contact
Regulation Number
886.1850
More FDA Info for this Regulation Number
Classification Product Code
HJO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/18/2014
Decision Date
10/15/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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