FDA 510(k) Application Details - K011392

Device Classification Name Folders And Injectors, Intraocular Lens (Iol)

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510(K) Number K011392
Device Name Folders And Injectors, Intraocular Lens (Iol)
Applicant MICRA INSTRUMENTS
52 BILTON WAY,
LUTON, BEDFORDSHIRE LU1 1UU GB
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Contact JOHN A.K. BASKERVILLE
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Regulation Number 886.4300

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Classification Product Code MSS
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Date Received 05/07/2001
Decision Date 10/22/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee OP - Ophthalmic
Review Advisory Committee OP - Ophthalmic
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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