The following data is part of a premarket notification filed by Imagyn Surgical with the FDA for 15mm Siteselect Breast Biopsy Device, 10 Mm Siteselect Breast Biopsy Device, 5mm Siteselect Breast Biopsy Device.
| Device ID | K993936 |
| 510k Number | K993936 |
| Device Name: | 15MM SITESELECT BREAST BIOPSY DEVICE, 10 MM SITESELECT BREAST BIOPSY DEVICE, 5MM SITESELECT BREAST BIOPSY DEVICE |
| Classification | Instrument, Biopsy |
| Applicant | IMAGYN SURGICAL 8850 M-89 Richland, MI 49083 |
| Contact | Julie Powell |
| Correspondent | Julie Powell IMAGYN SURGICAL 8850 M-89 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 | 1999-11-19 |
| Decision Date | 1999-12-27 |
| Summary: | summary |