The following data is part of a premarket notification filed by Pin-point Care Corp. with the FDA for Evacore Fully Disposable Vacuum Assist Biopsy Device.
| Device ID | K150088 |
| 510k Number | K150088 |
| Device Name: | Evacore Fully Disposable Vacuum Assist Biopsy Device |
| Classification | Instrument, Biopsy |
| Applicant | Pin-Point Care Corp. N1723 Center Street Lebanon, WI 53047 |
| Contact | Jeff M Hathaway |
| Correspondent | Jeff M Hathaway Pin-Point Care Corp. N1723 Center Street Lebanon, WI 53047 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-16 |
| Decision Date | 2015-07-20 |
| Summary: | summary |