The following data is part of a premarket notification filed by Best Medical International, Inc. with the FDA for Best Breast Brachytherapy Applicator.
| Device ID | K042586 |
| 510k Number | K042586 |
| Device Name: | BEST BREAST BRACHYTHERAPY APPLICATOR |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| 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 | JAQ |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-22 |
| Decision Date | 2004-11-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841365118593 | K042586 | 000 |