The following data is part of a premarket notification filed by Orthopedic Equipment Co., Inc. with the FDA for Split Cervical Collar/head Halter.
| Device ID | K760869 |
| 510k Number | K760869 |
| Device Name: | SPLIT CERVICAL COLLAR/HEAD HALTER |
| Classification | Halter, Head, Traction |
| Applicant | ORTHOPEDIC EQUIPMENT CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HSS |
| CFR Regulation Number | 888.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-10-18 |
| Decision Date | 1976-11-01 |