Bandages Catalog Number: 101 to 220
FDA 510(k) K871495 · I M, Inc.
510(k) numberK871495
Submission
- Device name
- Bandages Catalog Number: 101 to 220
- Applicant
- I M, Inc.
Fairfield, NJ, US - Received
- April 16, 1987
- Decision date
- May 8, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| 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 |
More from Hospital Specialty Co.
| 510(k) | Device | Decision |
|---|---|---|
| K914600 | Neurological SpongeHBA · Traditional | 12/30/1992SE |
| K892389 | Biopsy KitLRO · Traditional | 07/17/1989SESD |
| K881363 | Syringe Prefilled with WaterKOD · Traditional | 06/23/1988SE |
| K880753 | Umbilical Cord ClampHFW · Traditional | 04/27/1988SE |
| K872741 | NutripumpFRN · Traditional | 10/20/1987SE |
| K863785 | Makler CatheterHDR · Traditional | 12/11/1986SE |
| K854155 | Sterile Saline SolutionKMJ · Traditional | 12/10/1985SE |
| K853287 | HuboutFPA · Traditional | 10/17/1985SE |
| K853288 | Feeding Units & TubesKNT · Traditional | 10/04/1985SE |
| K853286 | Staple Remover · Traditional | 08/21/1985SE |
Questions and answers
When was Bandages Catalog Number: 101 to 220 cleared by the FDA?
Bandages Catalog Number: 101 to 220 (K871495) received a 510(k) decision of Substantially Equivalent on May 8, 1987, 22 days after the submission was received.
What is the product code of K871495?
The FDA product code is NAD – Dressing, Wound, Occlusive, a Class I (low risk) device regulated under 21 CFR 878.4020.