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FDA 510(k) Application Details - K040837
Device Classification Name
Folders And Injectors, Intraocular Lens (Iol)
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510(K) Number
K040837
Device Name
Folders And Injectors, Intraocular Lens (Iol)
Applicant
MEDICEL AG
377 ROUTE 17 S
HASBROUCK HEIGHTS, NJ 07604 US
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Contact
GEORGE MYERS
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Regulation Number
886.4300
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Classification Product Code
MSS
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Date Received
03/31/2004
Decision Date
06/17/2004
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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