Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K042810
Device Classification Name
Keratome, Ac-Powered
More FDA Info for this Device
510(K) Number
K042810
Device Name
Keratome, Ac-Powered
Applicant
NORWOOD ABBEY , LTD.
63 WELLS RD.
CHELSEA HGTS., VICTORIA 3196 AU
Other 510(k) Applications for this Company
Contact
PAUL CLARK
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
10/12/2004
Decision Date
10/28/2004
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact