CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR


Device Classification Name

system, applicator, radionuclide, remote-controlled

510(k) Number K030110
Device Name CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR
Original Applicant
MICK RADIO-NUCLEAR INSTRUMENTS, INC.
521 homestead ave.
mount vernon, 
NY 
10550

Original Contact felix mick
Regulation Number 892.5700
Classification Product Code
JAQ  
Date Received 01/13/2003
Decision Date 04/03/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls