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FDA 510(k) Application Details - K984143
Device Classification Name
Unit, Phacofragmentation
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510(K) Number
K984143
Device Name
Unit, Phacofragmentation
Applicant
FIBRA SONICS, INC.
5312 N. ELSTON AVE.
CHICAGO, IL 60630 US
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Contact
ROBERT BROHM
Other 510(k) Applications for this Contact
Regulation Number
886.4670
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Classification Product Code
HQC
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More FDA Info for this Product Code
Date Received
11/18/1998
Decision Date
02/16/1999
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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