The following data is part of a premarket notification filed by Mick Radio-nuclear Instruments, Inc. with the FDA for Modification To Henschke Hdr Cervix Applicator And Hilaris/nori Hdr Cervix Applicator.
| Device ID | K040704 |
| 510k Number | K040704 |
| Device Name: | MODIFICATION TO HENSCHKE HDR CERVIX APPLICATOR AND HILARIS/NORI HDR CERVIX APPLICATOR |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | MICK RADIO-NUCLEAR INSTRUMENTS, INC. 521 HOMESTEAD AVE. Mount Vernon, NY 10550 |
| Contact | Felix Mick |
| Correspondent | Felix 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 | 2004-03-18 |
| Decision Date | 2004-06-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817330027290 | K040704 | 000 |
| 00817330020901 | K040704 | 000 |
| 00817330020895 | K040704 | 000 |
| 00817330020888 | K040704 | 000 |
| 00817330020864 | K040704 | 000 |
| 00817330020857 | K040704 | 000 |
| 00817330020840 | K040704 | 000 |
| 00817330020833 | K040704 | 000 |
| 00817330020826 | K040704 | 000 |
| 00817330020819 | K040704 | 000 |
| 00817330020918 | K040704 | 000 |
| 00817330020925 | K040704 | 000 |
| 00817330020932 | K040704 | 000 |
| 00817330027283 | K040704 | 000 |
| 00817330024497 | K040704 | 000 |
| 00817330024039 | K040704 | 000 |
| 00817330022196 | K040704 | 000 |
| 00817330022189 | K040704 | 000 |
| 00817330022172 | K040704 | 000 |
| 00817330022165 | K040704 | 000 |
| 00817330022158 | K040704 | 000 |
| 00817330022141 | K040704 | 000 |
| 00817330020000 | K040704 | 000 |