The following data is part of a premarket notification filed by Emergent Innovations, Ltd. with the FDA for Vagabond Soft Restraint System.
| Device ID | K982178 |
| 510k Number | K982178 |
| Device Name: | VAGABOND SOFT RESTRAINT SYSTEM |
| Classification | Restraint, Protective |
| Applicant | EMERGENT INNOVATIONS, LTD. PO BOX 40773 Indianapolis, IN 46240 |
| Contact | Duane R Elliott |
| Correspondent | Duane R Elliott EMERGENT INNOVATIONS, LTD. PO BOX 40773 Indianapolis, IN 46240 |
| Product Code | FMQ |
| CFR Regulation Number | 880.6760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-22 |
| Decision Date | 1999-01-26 |