Sam Chest Seal with Vavle; Sam Chest Seal
FDA 510(k) K102403 · Sam Medical Products
510(k) numberK102403
Submission
- Device name
- Sam Chest Seal with Vavle; Sam Chest Seal
- Applicant
- Sam Medical Products
Wilsonville, OR, US - Received
- August 24, 2010
- Decision date
- March 3, 2011
- 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 |
| 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 |
| K080524 | Centurion Sorbaview OTCNAD · Traditional | Tri-State Hospital Supply Corp. | 04/23/2008SE |
| 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 |
|---|---|---|
| K191488 | SAM IO Intraosseous Access SystemFMI · Traditional | 11/21/2019SE |
| K133121 | Chito-Sam 100,4IN X4IN,CHITO-SAM, 3IN X6FT, Chito-Sam 100,3IN X10FT, Chito-Sam Active…QSY · Traditional | 05/22/2014SE |
| K131561 | Sam Junctional TourniquetDXC · Traditional | 07/24/2013SE |
| K123694 | Sam Junctional TourniquetDXC · Traditional | 03/07/2013SE |
Questions and answers
When was Sam Chest Seal with Vavle; Sam Chest Seal cleared by the FDA?
Sam Chest Seal with Vavle; Sam Chest Seal (K102403) received a 510(k) decision of Substantially Equivalent on March 3, 2011, 191 days after the submission was received.
What is the product code of K102403?
The FDA product code is NAD – Dressing, Wound, Occlusive, a Class I (low risk) device regulated under 21 CFR 878.4020.