The following data is part of a premarket notification filed by Ferguson Medical with the FDA for Tumorlocalizer Mri.
| Device ID | K962615 |
| 510k Number | K962615 |
| Device Name: | TUMORLOCALIZER MRI |
| Classification | Strip, Test Isoniazid |
| Applicant | FERGUSON MEDICAL 3407 BAY AVE. Chico, CA 95973 -8619 |
| Contact | Frank Ferguson |
| Correspondent | Frank Ferguson FERGUSON MEDICAL 3407 BAY AVE. Chico, CA 95973 -8619 |
| Product Code | MIG |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-03 |
| Decision Date | 1998-03-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838072787 | K962615 | 000 |
| 00884838072770 | K962615 | 000 |
| 00884838072763 | K962615 | 000 |
| 00884838072756 | K962615 | 000 |
| 00884838072657 | K962615 | 000 |