The following data is part of a premarket notification filed by Bionix Development Corp. with the FDA for Standard Breast Boards; Deluxe Breast Board.
| Device ID | K905007 |
| 510k Number | K905007 |
| Device Name: | STANDARD BREAST BOARDS; DELUXE BREAST BOARD |
| Classification | Accelerator, Linear, Medical |
| Applicant | BIONIX DEVELOPMENT CORP. 757 WAREHOUSE RD. STE.G Toledo, OH 43615 |
| Contact | Richard A Wasserman |
| Correspondent | Richard A Wasserman BIONIX DEVELOPMENT CORP. 757 WAREHOUSE RD. STE.G Toledo, OH 43615 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-06 |
| Decision Date | 1991-02-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817740020928 | K905007 | 000 |
| 00817740020881 | K905007 | 000 |
| 00817740020874 | K905007 | 000 |
| 00817740020867 | K905007 | 000 |
| 00817740020850 | K905007 | 000 |