The following data is part of a premarket notification filed by Best Medical International, Inc. with the FDA for Best Multi-lumen Balloon Applicator For Brachytherapy.
| Device ID | K132097 |
| 510k Number | K132097 |
| Device Name: | BEST MULTI-LUMEN BALLOON APPLICATOR FOR BRACHYTHERAPY |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | BEST MEDICAL INTERNATIONAL, INC. 7643 FULLERTON RD. Springfield, VA 22153 |
| Contact | Dharmendra Thakur |
| Correspondent | Dharmendra Thakur 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 | 2013-07-08 |
| Decision Date | 2013-09-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841365115646 | K132097 | 000 |
| 00841365112799 | K132097 | 000 |
| 00841365112805 | K132097 | 000 |
| 00841365112812 | K132097 | 000 |
| 00841365112829 | K132097 | 000 |
| 00841365113178 | K132097 | 000 |
| 00841365113185 | K132097 | 000 |
| 00841365113192 | K132097 | 000 |
| 00841365113314 | K132097 | 000 |
| 00841365113833 | K132097 | 000 |
| 00841365113840 | K132097 | 000 |
| 00841365114434 | K132097 | 000 |
| 00841365114748 | K132097 | 000 |
| 00841365115622 | K132097 | 000 |
| 00841365115639 | K132097 | 000 |
| 00841365106941 | K132097 | 000 |