The following data is part of a premarket notification filed by Richard's Medical Equip., Inc. with the FDA for Collar, Cervical, Split.
| Device ID | K780136 |
| 510k Number | K780136 |
| Device Name: | COLLAR, CERVICAL, SPLIT |
| Classification | Orthosis, Cervical |
| Applicant | RICHARD'S MEDICAL EQUIP., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IQK |
| CFR Regulation Number | 890.3490 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-01-25 |
| Decision Date | 1978-01-31 |