The following data is part of a premarket notification filed by Mick Radio-nuclear Instruments, Inc. with the FDA for Hdr Contour Tp Template And Implant Accessories.
| Device ID | K993400 |
| 510k Number | K993400 |
| Device Name: | HDR CONTOUR TP TEMPLATE AND IMPLANT ACCESSORIES |
| 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 | 1999-10-08 |
| Decision Date | 2000-01-06 |
| Summary: | summary |