The following data is part of a premarket notification filed by Bebig, Inc. with the FDA for Bebig Plaques Rum101-rum114.
| Device ID | K931393 |
| 510k Number | K931393 |
| Device Name: | BEBIG PLAQUES RUM101-RUM114 |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | BEBIG, INC. 65 COOPER SQUARE #4 New York, NY 10003 |
| Contact | Dr. A Eckert |
| Correspondent | Dr. A Eckert BEBIG, INC. 65 COOPER SQUARE #4 New York, NY 10003 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-19 |
| Decision Date | 1994-03-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049223104924 | K931393 | 000 |
| 04049223100926 | K931393 | 000 |
| 04049223100919 | K931393 | 000 |
| 04049223100902 | K931393 | 000 |
| 04049223100896 | K931393 | 000 |
| 04049223100889 | K931393 | 000 |
| 04049223100872 | K931393 | 000 |
| 04049223100865 | K931393 | 000 |
| 04049223100858 | K931393 | 000 |
| 04049223100841 | K931393 | 000 |
| 04049223100834 | K931393 | 000 |
| 04049223100827 | K931393 | 000 |
| 04049223100810 | K931393 | 000 |
| 04049223100803 | K931393 | 000 |
| 04049223100797 | K931393 | 000 |
| 04049223100780 | K931393 | 000 |
| 04049223100773 | K931393 | 000 |
| 04049223100766 | K931393 | 000 |
| 04049223100933 | K931393 | 000 |
| 04049223100940 | K931393 | 000 |
| 04049223104917 | K931393 | 000 |
| 04049223104900 | K931393 | 000 |
| 04049223104894 | K931393 | 000 |
| 04049223104887 | K931393 | 000 |
| 04049223104870 | K931393 | 000 |
| 04049223104863 | K931393 | 000 |
| 04049223104856 | K931393 | 000 |
| 04049223104849 | K931393 | 000 |
| 04049223104832 | K931393 | 000 |
| 04049223104825 | K931393 | 000 |
| 04049223104818 | K931393 | 000 |
| 04049223104801 | K931393 | 000 |
| 04049223104795 | K931393 | 000 |
| 04049223104788 | K931393 | 000 |
| 04049223100971 | K931393 | 000 |
| 04049223100964 | K931393 | 000 |
| 04049223100957 | K931393 | 000 |
| 04049223100759 | K931393 | 000 |