Centurion Sorbaview OTC
FDA 510(k) K080524 · Tri-State Hospital Supply Corp.
510(k) numberK080524
Submission
- Device name
- Centurion Sorbaview OTC
- Applicant
- Tri-State Hospital Supply Corp.
Howell, MI, US - Received
- February 26, 2008
- Decision date
- April 23, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NAD – Dressing, Wound, Occlusive
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4020
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code NAD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254246 | LT Antibacterial Foam with Silver DressingNAD · Traditional | Zhejiang Longterm Medical Technology Co., Ltd. | 09/10/2026SE |
| K102403 | Sam Chest Seal with Vavle; Sam Chest SealNAD · Traditional | Sam Medical Products | 03/03/2011SE |
| K091133 | Aplion Topical Care SystemNAD · Traditional | Aplion Medical,Llc | 05/20/2009SE |
| K072560 | Envela (Hydrohesive Occlusive Dressing)NAD · Traditional | Teikoku Pharma USA, Inc. | 06/17/2008SE |
| K060046 | DermastreamNAD · Traditional | Enzysurge , Ltd. | 02/27/2006SE |
| K043063 | Oxyband Wound DressingNAD · Traditional | Oxyband Technologies, Inc. | 03/24/2005SE |
| K020781 | Wet ChamberNAD · Traditional | Kinetic Concepts, Inc. | 05/06/2002SE |
| K990530 | Kerlix MD Antimicrobial Gauze DressingNAD · Traditional | The Kendall Company, L.P. | 01/31/2000SE |
| K990861 | Wound Dressing/Abd Pad, Model #10810NAD · Traditional | Hospital Specialty Co. | 04/12/1999SE |
| K964534 | Otosilk Otological Graft DressingNAD · Traditional | Boston Medical Products, Inc. | 04/09/1997SE |
More from Boston Medical Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K080448 | Centurion Protective Restraint, SCR SeriesFMQ · Traditional | 08/28/2008SE |
| 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 Sorbaview OTC cleared by the FDA?
Centurion Sorbaview OTC (K080524) received a 510(k) decision of Substantially Equivalent on April 23, 2008, 57 days after the submission was received.
What is the product code of K080524?
The FDA product code is NAD – Dressing, Wound, Occlusive, a Class I (low risk) device regulated under 21 CFR 878.4020.