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FDA 510(k) Application Details - K961512
Device Classification Name
Tonometer, Manual
More FDA Info for this Device
510(K) Number
K961512
Device Name
Tonometer, Manual
Applicant
CLEMENT CLARKE, INC.
AIRMED HOUSE, EDINBURGH WAY
HARLOW, ESSEX CM20 2ED
ENGLAND GB
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Contact
MICHAEL J WILKINSON
Other 510(k) Applications for this Contact
Regulation Number
886.1930
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Classification Product Code
HKY
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More FDA Info for this Product Code
Date Received
04/19/1996
Decision Date
07/18/1996
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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