Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K112176
Device Classification Name
Implant, Eye Sphere
More FDA Info for this Device
510(K) Number
K112176
Device Name
Implant, Eye Sphere
Applicant
OCULO PLASTIK, INC.
200 SAUVE WEST
MONTREAL, QC H3L 1Y9 CA
Other 510(k) Applications for this Company
Contact
SYLVAIN DESROSIERS
Other 510(k) Applications for this Contact
Regulation Number
886.3320
More FDA Info for this Regulation Number
Classification Product Code
HPZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/28/2011
Decision Date
09/15/2011
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