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FDA 510(k) Application Details - K022637
Device Classification Name
Keratome, Battery-Powered
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510(K) Number
K022637
Device Name
Keratome, Battery-Powered
Applicant
BECTON DICKINSON & CO.
1 BECTON DR.
FRANKLIN LAKES, NJ 07417-1885 US
Other 510(k) Applications for this Company
Contact
EILEEN T SCHWEIGHARDT
Other 510(k) Applications for this Contact
Regulation Number
886.4370
More FDA Info for this Regulation Number
Classification Product Code
HMY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/08/2002
Decision Date
10/16/2002
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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