FDA 510(k) Application Details - K051414

Device Classification Name Cup, Eye

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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
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Regulation Number 000.0000

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Classification Product Code LXQ
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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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