The following data is part of a premarket notification filed by Bip Usa, Inc. with the FDA for Vacuflash Biopsy System.
| Device ID | K024089 |
| 510k Number | K024089 |
| Device Name: | VACUFLASH BIOPSY SYSTEM |
| Classification | Instrument, Biopsy |
| Applicant | BIP USA, INC. 345 THIRD ST., SUITE 400 Niagara Falls, NY 14303 |
| Contact | Siegfried Gruchot |
| Correspondent | Siegfried Gruchot BIP USA, INC. 345 THIRD ST., SUITE 400 Niagara Falls, NY 14303 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-11 |
| Decision Date | 2003-03-11 |
| Summary: | summary |