Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K984540
Device Classification Name
Keratome, Ac-Powered
More FDA Info for this Device
510(K) Number
K984540
Device Name
Keratome, Ac-Powered
Applicant
KERAVISION, INC.
555 THIRTEENTH STREET, N.W.
WASHINGTON, DC 20004-1109 US
Other 510(k) Applications for this Company
Contact
HOWARD H HOLSTEIN
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
12/21/1998
Decision Date
04/28/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact