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FDA 510(k) Application Details - K021640
Device Classification Name
Keratome, Ac-Powered
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510(K) Number
K021640
Device Name
Keratome, Ac-Powered
Applicant
BAUSCH & LOMB, INC.
3365 TREE CT. INDUSTRIAL BLVD.
ST. LOUIS, MO 63122-6694 US
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DENNIS POZZO
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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
05/20/2002
Decision Date
06/19/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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