The following data is part of a premarket notification filed by Integra Radionics, Inc. with the FDA for Integra Radionics Interfix Patient Adapters.
| Device ID | K072454 |
| 510k Number | K072454 |
| Device Name: | INTEGRA RADIONICS INTERFIX PATIENT ADAPTERS |
| Classification | Accelerator, Linear, Medical |
| Applicant | INTEGRA RADIONICS, INC. 22 TERRY AVENUE Burlington, MA 01803 |
| Contact | Kevin J O'connell |
| Correspondent | Kevin J O'connell INTEGRA RADIONICS, INC. 22 TERRY AVENUE Burlington, MA 01803 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-31 |
| Decision Date | 2007-10-16 |
| Summary: | summary |