The following data is part of a premarket notification filed by Mick Radio-nuclear Instruments, Inc. with the FDA for Vaginal Applicator Shielded.
| Device ID | K001544 |
| 510k Number | K001544 |
| Device Name: | VAGINAL APPLICATOR SHIELDED |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | MICK RADIO-NUCLEAR INSTRUMENTS, INC. 1470 OUTLOOK AVE. P.O. BOX 99 Bronx, NY 10465 |
| Contact | Felix Mick |
| Correspondent | Felix Mick MICK RADIO-NUCLEAR INSTRUMENTS, INC. 1470 OUTLOOK AVE. P.O. BOX 99 Bronx, NY 10465 |
| Product Code | JAQ |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-18 |
| Decision Date | 2000-11-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817330024022 | K001544 | 000 |
| 00817330021489 | K001544 | 000 |
| 00817330021496 | K001544 | 000 |
| 00817330021502 | K001544 | 000 |
| 00817330021519 | K001544 | 000 |
| 00817330021526 | K001544 | 000 |
| 00817330021533 | K001544 | 000 |
| 00817330021540 | K001544 | 000 |
| 00817330021557 | K001544 | 000 |
| 00817330021564 | K001544 | 000 |
| 00817330021571 | K001544 | 000 |
| 00817330022974 | K001544 | 000 |
| 00817330023964 | K001544 | 000 |
| 00817330023971 | K001544 | 000 |
| 00817330023988 | K001544 | 000 |
| 00817330023995 | K001544 | 000 |
| 00817330024008 | K001544 | 000 |
| 00817330024015 | K001544 | 000 |
| 00817330021472 | K001544 | 000 |