Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K090587
Device Classification Name
Orthosis, Cranial, Laser Scan
More FDA Info for this Device
510(K) Number
K090587
Device Name
Orthosis, Cranial, Laser Scan
Applicant
ORTHOMERICA PRODUCTS, INC.
6333 N. ORANGE BLOSSOM TRAIL
ORLANDO, FL 32810 US
Other 510(k) Applications for this Company
Contact
ALAN T SANDIFER
Other 510(k) Applications for this Contact
Regulation Number
882.5970
More FDA Info for this Regulation Number
Classification Product Code
OAN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/04/2009
Decision Date
07/17/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact