The following data is part of a premarket notification filed by Best Medical Intl. with the FDA for Best Localization Needle With I-125 Seed.
| Device ID | K122704 |
| 510k Number | K122704 |
| Device Name: | BEST LOCALIZATION NEEDLE WITH I-125 SEED |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | BEST MEDICAL INTL. 7643 FULLERTON ROAD Springfield, VA 22153 |
| Contact | Dharmendra Thakur |
| Correspondent | Dharmendra Thakur BEST MEDICAL INTL. 7643 FULLERTON ROAD Springfield, VA 22153 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-04 |
| Decision Date | 2013-01-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841365107160 | K122704 | 000 |
| 00841365107153 | K122704 | 000 |
| 00841365107146 | K122704 | 000 |
| 00841365107139 | K122704 | 000 |
| 00841365107122 | K122704 | 000 |
| 00841365107115 | K122704 | 000 |
| 00841365107108 | K122704 | 000 |
| 00841365107092 | K122704 | 000 |