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FDA 510(k) Application Details - K080681
Device Classification Name
Camera, Ophthalmic, Ac-Powered
More FDA Info for this Device
510(K) Number
K080681
Device Name
Camera, Ophthalmic, Ac-Powered
Applicant
KOWA CO. LTD.
4-14, NIHONBASHI-HONCHO
3-CHOME
CHUO-KU, TOKYO 103-8433 JP
Other 510(k) Applications for this Company
Contact
SATOHIKO TAKANASHI
Other 510(k) Applications for this Contact
Regulation Number
886.1120
More FDA Info for this Regulation Number
Classification Product Code
HKI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/10/2008
Decision Date
04/04/2008
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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