FDA 510(k) Application Details - K010305

Device Classification Name Cannula, Ophthalmic

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510(K) Number K010305
Device Name Cannula, Ophthalmic
Applicant MICRON SURGICAL, INC.
5800 COLONIAL DR.
SUITE 300
MARGATE, FL 33063 US
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Contact APRIL DEAN
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Regulation Number 886.4350

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Classification Product Code HMX
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Date Received 02/01/2001
Decision Date 05/02/2001
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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