510(k) K022705

READI-STRAND, MODEL PSSTRAND by Worldwide Medical Technologies, LLC — Product Code KXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 2003
Date Received
August 14, 2002
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