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FDA 510(k) Application Details - K051414
Device Classification Name
Cup, Eye
More FDA Info for this Device
510(K) Number
K051414
Device Name
Cup, Eye
Applicant
TOLLOT PTY.LTD.(AAXIS PACIFIC)
13 RED FOX LANE
LITTLETON, CO 80127 US
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Contact
Kevin Walls
Other 510(k) Applications for this Contact
Regulation Number
000.0000
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Classification Product Code
LXQ
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More FDA Info for this Product Code
Date Received
05/31/2005
Decision Date
06/16/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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