The following data is part of a premarket notification filed by Bebig Trade, Inc. with the FDA for Bebig Inactive Ophthalmic Applicators For Iodine 125 Seeds.
| Device ID | K945983 |
| 510k Number | K945983 |
| Device Name: | BEBIG INACTIVE OPHTHALMIC APPLICATORS FOR IODINE 125 SEEDS |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | BEBIG TRADE, INC. 100 W. MONROE ST., SUITE 1101 Chicago, IL 60603 |
| Contact | Peter U Nilsen |
| Correspondent | Peter U Nilsen BEBIG TRADE, INC. 100 W. MONROE ST., SUITE 1101 Chicago, IL 60603 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-08 |
| Decision Date | 1995-10-18 |