The following data is part of a premarket notification filed by B. Braun Of America, Inc. with the FDA for Discography Kit.
| Device ID | K910503 |
| 510k Number | K910503 |
| Device Name: | DISCOGRAPHY KIT |
| Classification | System, X-ray, Photofluorographic |
| Applicant | B. BRAUN OF AMERICA, INC. 824 TWELFTH AVE. PO BOX 4027 Bethlehem, PA 18018 -0027 |
| Contact | Peggy Keiffer |
| Correspondent | Peggy Keiffer B. BRAUN OF AMERICA, INC. 824 TWELFTH AVE. PO BOX 4027 Bethlehem, PA 18018 -0027 |
| Product Code | IZG |
| CFR Regulation Number | 892.1730 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-05 |
| Decision Date | 1991-10-07 |