FDA 510(k) Application Details - K030179

Device Classification Name Needle, Phacoemulsification, Reprocessed

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510(K) Number K030179
Device Name Needle, Phacoemulsification, Reprocessed
Applicant SURGICAL INSTRUMENTS SERVICE AND SAVINGS, INC.
723 CURTIS CT; PO BOX 2060
SISTERS, OR 97759 US
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Contact MARY ANN BARKER
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Regulation Number 886.4670

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Classification Product Code NKX
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Date Received 01/17/2003
Decision Date 01/24/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee OP - Ophthalmic
Review Advisory Committee OP - Ophthalmic
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party Y
Expedited Review



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