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FDA 510(k) Application Details - K060648
Device Classification Name
Needle, Phacoemulsification, Reprocessed
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510(K) Number
K060648
Device Name
Needle, Phacoemulsification, Reprocessed
Applicant
ALLIANCE MEDICAL CORP.
10232 SOUTH 51ST ST.
PHOENIX, AZ 85044 US
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MOIIRA BARTON
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Regulation Number
886.4670
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Classification Product Code
NKX
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More FDA Info for this Product Code
Date Received
03/13/2006
Decision Date
03/19/2007
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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