Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K991526
Device Classification Name
Source, Brachytherapy, Radionuclide
More FDA Info for this Device
510(K) Number
K991526
Device Name
Source, Brachytherapy, Radionuclide
Applicant
IMAGYN MEDICAL TECHNOLOGIES, INC.
3050 REDHILL AVE.
COSTA MESA, CA 92626 US
Other 510(k) Applications for this Company
Contact
CHERYL BLAKE
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
05/03/1999
Decision Date
06/17/1999
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