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FDA 510(k) Application Details - K032799
Device Classification Name
Tonometer, Ac-Powered
More FDA Info for this Device
510(K) Number
K032799
Device Name
Tonometer, Ac-Powered
Applicant
REICHERT INC.
3374 WALDEN AVE.
DEPEW, NY 14043 US
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Contact
FRANK DREXELIUS
Other 510(k) Applications for this Contact
Regulation Number
886.1930
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Classification Product Code
HKX
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More FDA Info for this Product Code
Date Received
09/09/2003
Decision Date
01/20/2004
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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