510(k) K915156

I-125 SEEDS CODE: 6702 by Medi-Physics Inc. Dba Nycomed Amersham Imaging — Product Code KXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 1992
Date Received
November 14, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Source, Brachytherapy, Radionuclide
Device Class
Class II
Regulation Number
892.5730
Review Panel
RA
Submission Type