The following data is part of a premarket notification filed by Today's Machining & Design, Inc. with the FDA for Froning Guidance System #tx-8200.
| Device ID | K823675 |
| 510k Number | K823675 |
| Device Name: | FRONING GUIDANCE SYSTEM #TX-8200 |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | TODAY'S MACHINING & DESIGN, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-12-07 |
| Decision Date | 1983-01-05 |