The following data is part of a premarket notification filed by Bip Usa, Inc. with the FDA for Bip Multi Modification.
| Device ID | K934371 |
| 510k Number | K934371 |
| Device Name: | BIP MULTI MODIFICATION |
| Classification | Instrument, Biopsy |
| Applicant | BIP USA, INC. CARBORUNDUM CENTER SUITE 480, 345 THIRD STREET Niagara Falls, NY 14303 |
| Contact | Gary Horner |
| Correspondent | Gary Horner BIP USA, INC. CARBORUNDUM CENTER SUITE 480, 345 THIRD STREET 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 | 1993-09-07 |
| Decision Date | 1994-04-28 |