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FDA 510(k) Application Details - K062465
Device Classification Name
Keratome, Ac-Powered
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510(K) Number
K062465
Device Name
Keratome, Ac-Powered
Applicant
BAUSCH & LOMB, INC.
1400 NORTH GOODMAN ST.
ROCHESTER, NY 14609-3547 US
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Contact
NED LUCE
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Regulation Number
886.4370
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Classification Product Code
HNO
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More FDA Info for this Product Code
Date Received
08/24/2006
Decision Date
09/06/2006
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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