The following data is part of a premarket notification filed by Best Medical International, Inc. with the FDA for Best Strand And Best Spacer.
| Device ID | K061638 |
| 510k Number | K061638 |
| Device Name: | BEST STRAND AND BEST SPACER |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | BEST MEDICAL INTERNATIONAL, INC. 7643 FULLERTON RD. Springfield, VA 22153 |
| Contact | Michael J Phelan |
| Correspondent | Michael J Phelan BEST MEDICAL INTERNATIONAL, INC. 7643 FULLERTON RD. 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 | 2006-06-12 |
| Decision Date | 2006-08-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841365113567 | K061638 | 000 |
| 00841365112867 | K061638 | 000 |
| 00841365112522 | K061638 | 000 |
| 00841365107603 | K061638 | 000 |
| 00841365106958 | K061638 | 000 |