The following data is part of a premarket notification filed by Best Medical International, Inc. with the FDA for Best Model # 81-01 Series Ir-192 Sources.
| Device ID | K042786 |
| 510k Number | K042786 |
| Device Name: | BEST MODEL # 81-01 SERIES IR-192 SOURCES |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | BEST MEDICAL INTERNATIONAL, INC. 7643 FULLERTON RD. Springfield, VA 22153 |
| Contact | Joseph C Wang |
| Correspondent | Joseph C Wang BEST MEDICAL INTERNATIONAL, INC. 7643 FULLERTON RD. Springfield, VA 22153 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-06 |
| Decision Date | 2004-11-18 |
| Summary: | summary |