The following data is part of a premarket notification filed by Invivo Corp. with the FDA for Model Bbd Breast Immobilization And Biopsy Device.
| Device ID | K052704 |
| 510k Number | K052704 |
| Device Name: | MODEL BBD BREAST IMMOBILIZATION AND BIOPSY DEVICE |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | INVIVO CORP. N27 W23676 PAUL ROAD Pewaukee, WI 53072 |
| Contact | Thomas E Tynes |
| Correspondent | Thomas E Tynes INVIVO CORP. N27 W23676 PAUL ROAD Pewaukee, WI 53072 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-28 |
| Decision Date | 2005-11-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838073074 | K052704 | 000 |
| 00884838073050 | K052704 | 000 |