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FDA 510(k) Application Details - K981554
Device Classification Name
Keratome, Ac-Powered
More FDA Info for this Device
510(K) Number
K981554
Device Name
Keratome, Ac-Powered
Applicant
MICRA INSTRUMENTS LTD.
52 BILTON WAY
LUTON LU1 1UU GB
Other 510(k) Applications for this Company
Contact
JOHN A.K. BASKERVILLE
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
05/01/1998
Decision Date
12/22/1998
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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