The following data is part of a premarket notification filed by Bip Usa, Inc. with the FDA for Breast Stabilizer.
| Device ID | K925874 |
| 510k Number | K925874 |
| Device Name: | BREAST STABILIZER |
| Classification | Instrument, Manual, Surgical, General Use |
| Applicant | BIP USA, INC. 727 MAIN ST. Niagara Falls, NY 14301 |
| Contact | Gary Horner |
| Correspondent | Gary Horner BIP USA, INC. 727 MAIN ST. Niagara Falls, NY 14301 |
| Product Code | MDM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-19 |
| Decision Date | 1993-03-16 |