Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K082950
Device Classification Name
Orthosis, Cranial, Laser Scan
More FDA Info for this Device
510(K) Number
K082950
Device Name
Orthosis, Cranial, Laser Scan
Applicant
ORTHOMERICA PRODUCTS, INC.
6333 NORTH 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
10/03/2008
Decision Date
12/05/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact