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FDA 510(k) Application Details - K053430
Device Classification Name
Tonometer, Manual
More FDA Info for this Device
510(K) Number
K053430
Device Name
Tonometer, Manual
Applicant
MEDTRONIC XOMED, INC.
6743 SOUTHPOINT DR. NORTH
JACKSONVILLE, FL 32216 US
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Contact
PENNY LAYMAN
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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
12/09/2005
Decision Date
03/03/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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