The following data is part of a premarket notification filed by Best Medical International, Inc. with the FDA for Best Instruminal Applicator.
| Device ID | K162499 |
| 510k Number | K162499 |
| Device Name: | Best Instruminal Applicator |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | BEST MEDICAL INTERNATIONAL, INC. 7643 FULLERTON ROAD Springfield, VA 22153 |
| Contact | Manny Subramanian |
| Correspondent | Manny Subramanian BEST MEDICAL INTERNATIONAL, INC. 7643 FULLERTON ROAD 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 | 2016-09-07 |
| Decision Date | 2018-04-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841365117107 | K162499 | 000 |