The following data is part of a premarket notification filed by Comfortex, Inc. with the FDA for Murphy Adjustable Splint.
| Device ID | K854270 |
| 510k Number | K854270 |
| Device Name: | MURPHY ADJUSTABLE SPLINT |
| Classification | Component, Traction, Non-invasive |
| Applicant | COMFORTEX, INC. 420 MAIN ST. Winona, MN 55987 |
| Contact | Donald M Salyards |
| Correspondent | Donald M Salyards COMFORTEX, INC. 420 MAIN ST. Winona, MN 55987 |
| Product Code | KQZ |
| CFR Regulation Number | 888.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-23 |
| Decision Date | 1985-12-09 |