Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K151285
Device Classification Name
More FDA Info for this Device
510(K) Number
K151285
Device Name
VSP Cranial System
Applicant
3D Systems, Inc.
17301 West Colfax Avenue, Suite 300
Golden, CO 80401 US
Other 510(k) Applications for this Company
Contact
Kim Torluemke
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PPT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/14/2015
Decision Date
09/23/2016
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