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FDA 510(k) Application Details - K020079
Device Classification Name
Keratome, Ac-Powered
More FDA Info for this Device
510(K) Number
K020079
Device Name
Keratome, Ac-Powered
Applicant
BLADE WORKS, INC.
1816 TOWHEE ST.
SAN MARCOS, CA 92069 US
Other 510(k) Applications for this Company
Contact
MARK MOYER
Other 510(k) Applications for this Contact
Regulation Number
886.4370
More FDA Info for this Regulation Number
Classification Product Code
HNO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/10/2002
Decision Date
04/19/2002
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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