The following data is part of a premarket notification filed by Vivaray, Inc. with the FDA for Capri Applicator.
| Device ID | K092822 |
| 510k Number | K092822 |
| Device Name: | CAPRI APPLICATOR |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | VIVARAY, INC. 3264 ALPINE ROAD Portola Valley, CA 94028 |
| Contact | George Hermann |
| Correspondent | George Hermann VIVARAY, INC. 3264 ALPINE ROAD Portola Valley, CA 94028 |
| Product Code | JAQ |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-14 |
| Decision Date | 2009-11-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816389021402 | K092822 | 000 |