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FDA 510(k) Application Details - K081756
Device Classification Name
Tonometer, Ac-Powered
More FDA Info for this Device
510(K) Number
K081756
Device Name
Tonometer, Ac-Powered
Applicant
REICHERT INC.
3362 WALDEN AVE.
DEPEW, NY 14043 US
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Contact
SANDRA BROWN
Other 510(k) Applications for this Contact
Regulation Number
886.1930
More FDA Info for this Regulation Number
Classification Product Code
HKX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/20/2008
Decision Date
08/07/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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