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FDA 510(k) Application Details - K983129
Device Classification Name
Lens, Guide, Intraocular
More FDA Info for this Device
510(K) Number
K983129
Device Name
Lens, Guide, Intraocular
Applicant
STAAR SURGICAL CO.
1911 WALKER AVE.
MONROVIA, CA 91016 US
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Contact
STEVEN L ZIEMBA
Other 510(k) Applications for this Contact
Regulation Number
886.4300
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Classification Product Code
KYB
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More FDA Info for this Product Code
Date Received
09/08/1998
Decision Date
12/04/1998
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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