The following data is part of a premarket notification filed by Imagyn Surgical with the FDA for 22mm Siteselect Breast Biopsy Device Model Ssd022.
| Device ID | K011575 |
| 510k Number | K011575 |
| Device Name: | 22MM SITESELECT BREAST BIOPSY DEVICE MODEL SSD022 |
| Classification | Instrument, Biopsy |
| Applicant | IMAGYN SURGICAL 8850 M-89 PO BOX 351 Richland, MI 49083 |
| Contact | Julie Powell |
| Correspondent | Julie Powell IMAGYN SURGICAL 8850 M-89 PO BOX 351 Richland, MI 49083 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-22 |
| Decision Date | 2001-08-17 |
| Summary: | summary |