The following data is part of a premarket notification filed by Mick Radio-nuclear Instruments, Inc. with the FDA for Mick Hdr Interstitial Implant Accessories.
| Device ID | K051423 |
| 510k Number | K051423 |
| Device Name: | MICK HDR INTERSTITIAL IMPLANT ACCESSORIES |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | MICK RADIO-NUCLEAR INSTRUMENTS, INC. 521 HOMESTEAD AVE. Mount Vernon, NY 10550 |
| Contact | Felix Miok |
| Correspondent | Felix Miok 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 | 2005-06-01 |
| Decision Date | 2005-07-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815165020783 | K051423 | 000 |
| 00817330027351 | K051423 | 000 |
| 00817330026712 | K051423 | 000 |