Device Classification Name |
Accelerator, Linear, Medical
|
510(k) Number |
K072454 |
Device Name |
INTEGRA RADIONICS INTERFIX PATIENT ADAPTERS |
Applicant |
INTEGRA RADIONICS, INC. |
22 TERRY AVENUE |
BURLINGTON,
MA
01803
|
|
Applicant Contact |
KEVIN J O'CONNELL |
Correspondent |
INTEGRA RADIONICS, INC. |
22 TERRY AVENUE |
BURLINGTON,
MA
01803
|
|
Correspondent Contact |
KEVIN J O'CONNELL |
Regulation Number | 892.5050
|
Classification Product Code |
|
Date Received | 08/31/2007 |
Decision Date | 10/16/2007 |
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
|
|
|