Centurion Protective Restraint, SCR Series
FDA 510(k) K080448 · Tri-State Hospital Supply Corp.
510(k) numberK080448
Submission
- Device name
- Centurion Protective Restraint, SCR Series
- Applicant
- Tri-State Hospital Supply Corp.
Howell, MI, US - Received
- February 19, 2008
- Decision date
- August 28, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FMQ – Restraint, Protective
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6760
- Specialty
- General Hospital
Other 510(k)s with product code FMQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K110377 | Protective RestraintFMQ · Traditional | Medi-Tech Intl. Corp. | 04/25/2011SE |
| K081264 | Statstrap Neonatal Incubator Safety Strap, Models SS-001, SS-002FMQ · Traditional | Children'S Health First, Inc. | 02/13/2009SE |
| K013239 | Comfortcare Compression Support with Magnets Comfortcare Magnetic InsolesFMQ · Traditional | Med Gen, Inc. | 11/20/2001SE |
| K010818 | Infant Limb Holder, Models 306080 & 306081FMQ · Traditional | Skil-Care Corp. | 05/24/2001SE |
| K010644 | Cinch-Type Disposable Limb Holders, Model 912025FMQ · Traditional | Skil-Care Corp. | 05/18/2001SE |
| K991591 | Biothane Patient RestraintFMQ · Traditional | Bioplastics | 07/29/1999SE |
| K982178 | Vagabond Soft Restraint SystemFMQ · Traditional | Emergent Innovations, Ltd. | 01/26/1999SE |
| K980640 | Heelbo Waist and Chest VestFMQ · Traditional | Heelbo, Inc. | 05/01/1998SE |
| K972446 | Pedo Cush Pedo CuddleFMQ · Traditional | Cavity Free Kids, Inc. | 11/13/1997SE |
| K972046 | Full Body Restraint SystemFMQ · Traditional | Gillen Industries | 08/15/1997SE |
More from Gillen Industries
| 510(k) | Device | Decision |
|---|---|---|
| K080524 | Centurion Sorbaview OTCNAD · Traditional | 04/23/2008SE |
| K942353 | Centurion Umbilical CatheterFOS · Traditional | 08/15/1995SE |
| K945977 | Centurion(R) Site Guard(R) Transparent Dressing/Transpaent Film DressingMGP · Traditional | 03/29/1995SE |
| K931748 | Centlurion Disp Steri Dental/Hygiene Pack/TraysLJT · Traditional | 02/25/1994SESK |
| K935491 | Centurion Mogen Clamp/Circumcision (Ster/Non Ster)HFX · Traditional | 02/17/1994SE |
| K923812 | Centurion Disposable InstrumentsMDM · Traditional | 12/17/1992SE |
| K910906 | Centurion Kleen-Needle System I.V. Extension SetsFPK · Traditional | 04/01/1991SE |
| K897100 | Centurion Vaginal SpeculumHIC · Traditional | 03/16/1990SE |
| K896320 | Centurion Kleen-Needle SystemFMI · Traditional | 01/11/1990SE |
| K893647 | Copolyester Film DressingKGN · Traditional | 10/16/1989SE |
Questions and answers
When was Centurion Protective Restraint, SCR Series cleared by the FDA?
Centurion Protective Restraint, SCR Series (K080448) received a 510(k) decision of Substantially Equivalent on August 28, 2008, 191 days after the submission was received.
What is the product code of K080448?
The FDA product code is FMQ – Restraint, Protective, a Class I (low risk) device regulated under 21 CFR 880.6760.