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FDA 510(k) Application Details - K981432
Device Classification Name
Tonometer, Manual
More FDA Info for this Device
510(K) Number
K981432
Device Name
Tonometer, Manual
Applicant
GOLDEN VISION, INC.
7436 S.W. 117TH AVE.,SUITE 103
MIAMI, FL 33183-3816 US
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Contact
ANDRES R QUIROZ
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
04/20/1998
Decision Date
01/12/1999
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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