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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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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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