Device Classification Name |
Source, Brachytherapy, Radionuclide
|
510(k) Number |
K063177 |
Device Name |
RAPID STRAND RX |
Applicant |
ONCURA INC. |
43 PALMETTO WAY |
NORTH BRUNSWICK,
NJ
08902
|
|
Applicant Contact |
SUBHASH PATEL |
Correspondent |
ONCURA INC. |
43 PALMETTO WAY |
NORTH BRUNSWICK,
NJ
08902
|
|
Correspondent Contact |
SUBHASH PATEL |
Regulation Number | 892.5730
|
Classification Product Code |
|
Date Received | 10/19/2006 |
Decision Date | 11/30/2006 |
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
|
|
|