The following data is part of a premarket notification filed by Mick Radio-nuclear Instruments, Inc. with the FDA for Extended Tumor Caliper.
| Device ID | K811278 |
| 510k Number | K811278 |
| Device Name: | EXTENDED TUMOR CALIPER |
| Classification | Tape, Measuring, Rulers And Calipers |
| Applicant | MICK RADIO-NUCLEAR INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FTY |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-05-08 |
| Decision Date | 1981-06-02 |