Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K041213
Device Classification Name
More FDA Info for this Device
510(K) Number
K041213
Device Name
3DSCOPE
Applicant
DIREX SYSTEMS CORP.
11 MERCER RD.
NATICK, MA 01760 US
Other 510(k) Applications for this Company
Contact
LARISA GERSHTEIN
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OXO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/10/2004
Decision Date
07/22/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact