Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K003206
Device Classification Name
Source, Brachytherapy, Radionuclide
More FDA Info for this Device
510(K) Number
K003206
Device Name
Source, Brachytherapy, Radionuclide
Applicant
PROXIMA THERAPEUTICS, INC.
2555 MARCONI DRIVE, SUITE 220
ALPHARETTA, GA 30005-2066 US
Other 510(k) Applications for this Company
Contact
DEBORAH J MOORE
Other 510(k) Applications for this Contact
Regulation Number
892.5730
More FDA Info for this Regulation Number
Classification Product Code
KXK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/13/2000
Decision Date
04/25/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact