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FDA 510(k) Application Details - K001806
Device Classification Name
Keratome, Ac-Powered
More FDA Info for this Device
510(K) Number
K001806
Device Name
Keratome, Ac-Powered
Applicant
MILLENNIUM BIOMEDICAL, INC.
360 EAST BONITA AVE.
POMONA, CA 91767 US
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Contact
JERRY KAENI
Other 510(k) Applications for this Contact
Regulation Number
886.4370
More FDA Info for this Regulation Number
Classification Product Code
HNO
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More FDA Info for this Product Code
Date Received
06/15/2000
Decision Date
09/12/2000
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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