The following data is part of a premarket notification filed by Friddle's Orthopedic Appliances, Inc. with the FDA for Friddle Halo System, Friddle Mri Halo System.
| Device ID | K980689 |
| 510k Number | K980689 |
| Device Name: | FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM |
| Classification | Tong, Skull For Traction |
| Applicant | FRIDDLE'S ORTHOPEDIC APPLIANCES, INC. 12306 BELTON HONEA PATH HWY. Honea Path, SC 29654 |
| Contact | Frank E Friddle, Jr. |
| Correspondent | Frank E Friddle, Jr. FRIDDLE'S ORTHOPEDIC APPLIANCES, INC. 12306 BELTON HONEA PATH HWY. Honea Path, SC 29654 |
| Product Code | HAX |
| CFR Regulation Number | 882.5960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-23 |
| Decision Date | 1999-02-18 |
| Summary: | summary |