The following data is part of a premarket notification filed by Biolucent, Inc. with the FDA for Biolucent Mammography Cushion.
| Device ID | K003795 |
| 510k Number | K003795 |
| Device Name: | BIOLUCENT MAMMOGRAPHY CUSHION |
| Classification | System, X-ray, Mammographic |
| Applicant | BIOLUCENT, INC. 27121 ALISO CREEK RD. SUITE 125 Aliso Viejo, CA 92656 |
| Contact | Steve Gex |
| Correspondent | Steve Gex BIOLUCENT, INC. 27121 ALISO CREEK RD. SUITE 125 Aliso Viejo, CA 92656 |
| Product Code | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-08 |
| Decision Date | 2001-02-14 |