FDA 510(k) Application Details - K023045

Device Classification Name Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla

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510(K) Number K023045
Device Name Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla
Applicant MERIDIAN AG
BIERIGUTSTRASSE 7
THUN, BERN 3608 CH
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Contact KURT FREY
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Regulation Number 886.4392

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Classification Product Code LXS
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Date Received 09/12/2002
Decision Date 09/26/2002
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 Y
Expedited Review



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