The following data is part of a premarket notification filed by Abco Dealers, Inc. with the FDA for Cervical Collars & Head Halters.
| Device ID | K850465 |
| 510k Number | K850465 |
| Device Name: | CERVICAL COLLARS & HEAD HALTERS |
| Classification | Orthosis, Cervical |
| Applicant | ABCO DEALERS, INC. P.O. BOX 17587 6637 NORTH SIDNEY PLACE Milwaukee, WI 53217 |
| Contact | Christine Nemeth |
| Correspondent | Christine Nemeth ABCO DEALERS, INC. P.O. BOX 17587 6637 NORTH SIDNEY PLACE Milwaukee, WI 53217 |
| Product Code | IQK |
| CFR Regulation Number | 890.3490 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-28 |
| Decision Date | 1985-04-25 |