The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Finesse Ultra Breast Biospy System Driver - Blue, Pink, Probe Fo1blu, Foipnk, F14105us.
| Device ID | K093068 |
| 510k Number | K093068 |
| Device Name: | FINESSE ULTRA BREAST BIOSPY SYSTEM DRIVER - BLUE, PINK, PROBE FO1BLU, FOIPNK, F14105US |
| Classification | Instrument, Biopsy |
| Applicant | C.R. BARD, INC. 1415 W. 3RD P.O BOX 1740 Tempe, AZ 85280 -1740 |
| Contact | Cindy Moss |
| Correspondent | Robert Mosenkis CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-09-30 |
| Decision Date | 2009-11-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10801741085168 | K093068 | 000 |
| 10801741083935 | K093068 | 000 |
| 10801741083928 | K093068 | 000 |