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FDA 510(k) Application Details - K010260
Device Classification Name
Keratome, Ac-Powered
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510(K) Number
K010260
Device Name
Keratome, Ac-Powered
Applicant
BAUSCH & LOMB, INC.
9342 JERONIMO RD.
IRVINE, CA 92618 US
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Contact
PAUL S KRAMSKY
Other 510(k) Applications for this Contact
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
01/29/2001
Decision Date
04/27/2001
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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