The following data is part of a premarket notification filed by Mick Radio-nuclear Instruments, Inc. with the FDA for Ct Compatible F/s/d Applicators.
| Device ID | K063381 |
| 510k Number | K063381 |
| Device Name: | CT COMPATIBLE F/S/D APPLICATORS |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | MICK RADIO-NUCLEAR INSTRUMENTS, INC. 521 HOMESTEAD AVE. Mount Vernon, NY 10550 |
| Contact | Fleix Mick |
| Correspondent | Fleix Mick MICK RADIO-NUCLEAR INSTRUMENTS, INC. 521 HOMESTEAD AVE. Mount Vernon, NY 10550 |
| Product Code | JAQ |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-08 |
| Decision Date | 2006-12-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817330027771 | K063381 | 000 |
| 00817330021410 | K063381 | 000 |
| 00817330021403 | K063381 | 000 |
| 00817330021397 | K063381 | 000 |
| 00817330021380 | K063381 | 000 |
| 00817330021373 | K063381 | 000 |
| 00817330021366 | K063381 | 000 |
| 00817330021359 | K063381 | 000 |
| 00817330021342 | K063381 | 000 |
| 00817330021335 | K063381 | 000 |
| 00817330021328 | K063381 | 000 |
| 00817330021311 | K063381 | 000 |
| 00817330021304 | K063381 | 000 |
| 00817330021298 | K063381 | 000 |
| 00817330021793 | K063381 | 000 |
| 00817330021809 | K063381 | 000 |
| 00817330021816 | K063381 | 000 |
| 00817330027603 | K063381 | 000 |
| 00817330024480 | K063381 | 000 |
| 00817330024107 | K063381 | 000 |
| 00817330024091 | K063381 | 000 |
| 00817330024084 | K063381 | 000 |
| 00817330024077 | K063381 | 000 |
| 00817330024060 | K063381 | 000 |
| 00817330024053 | K063381 | 000 |
| 00817330024046 | K063381 | 000 |
| 00817330021854 | K063381 | 000 |
| 00817330021847 | K063381 | 000 |
| 00817330021830 | K063381 | 000 |
| 00817330021823 | K063381 | 000 |
| 00817330021281 | K063381 | 000 |