The following data is part of a premarket notification filed by Mick Radio-nuclear Instruments, Inc. with the FDA for Mick 200-tp And Mick Tp Needle.
| Device ID | K890341 |
| 510k Number | K890341 |
| Device Name: | MICK 200-TP AND MICK TP NEEDLE |
| Classification | System, Applicator, Radionuclide, Manual |
| Applicant | MICK RADIO-NUCLEAR INSTRUMENTS, INC. P.O. BOX 99 Bronx, NY 10465 |
| Contact | Felix W Mick |
| Correspondent | Felix W Mick MICK RADIO-NUCLEAR INSTRUMENTS, INC. P.O. BOX 99 Bronx, NY 10465 |
| Product Code | IWJ |
| CFR Regulation Number | 892.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-23 |
| Decision Date | 1989-03-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817330027740 | K890341 | 000 |
| 00817330021458 | K890341 | 000 |
| 00817330021786 | K890341 | 000 |
| 00817330027375 | K890341 | 000 |
| 00817330027382 | K890341 | 000 |
| 00817330027399 | K890341 | 000 |
| 00817330027405 | K890341 | 000 |
| 00817330027412 | K890341 | 000 |
| 00817330027641 | K890341 | 000 |
| 00817330027733 | K890341 | 000 |
| 00817330021434 | K890341 | 000 |