The following data is part of a premarket notification filed by Tri-state Hospital Supply Corp. with the FDA for Centurion Protective Restraint, Scr Series.
| Device ID | K080448 |
| 510k Number | K080448 |
| Device Name: | CENTURION PROTECTIVE RESTRAINT, SCR SERIES |
| Classification | Restraint, Protective |
| Applicant | TRI-STATE HOSPITAL SUPPLY CORP. 301 CATRELL DR. Howell, MI 48843 |
| Contact | Matthew K Price |
| Correspondent | Matthew K Price TRI-STATE HOSPITAL SUPPLY CORP. 301 CATRELL DR. Howell, MI 48843 |
| Product Code | FMQ |
| CFR Regulation Number | 880.6760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-19 |
| Decision Date | 2008-08-28 |
| Summary: | summary |