Hydrofera Bacteristatic Nasal Dressing
FDA 510(k) K983276 · Hydrofera, LLC
510(k) numberK983276
Submission
- Device name
- Hydrofera Bacteristatic Nasal Dressing
- Applicant
- Hydrofera, LLC
Willimantic, CT, US - Received
- September 17, 1998
- Decision date
- September 14, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- EMX – Balloon, Epistaxis
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.4100
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code EMX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K220326 | PosiSep X BAM Hemostat Dressing/Intranasal SplintEMX · Traditional | Hemostasis, LLC | 11/14/2022SE |
| K041446 | NasalceaseEMX · Traditional | Les Laboratorires Brothier, S.A. | 07/01/2004SE |
| K000108 | Rapid Rhino-Anterior 90MM, Model Rr-A 90, Rapid Rhino-Posterior 100MM, Model Rr-P 100EMX · Traditional | Bhk Holding | 05/23/2000SE |
| K993362 | HylasineEMX · Traditional | Biomatrix, Inc. | 03/13/2000SE |
| K982731 | Merogel Nasal Dressing and Sinus StentEMX · Traditional | Xomed, Inc. | 02/02/1999SE |
| K984069 | Entaxis Nasal PackingEMX · Traditional | Les Laboratorires Brothier, S.A. | 01/25/1999SE |
| K981966 | Nosebleed NoseclipEMX · Traditional | Michael M. Knott, M.D. | 08/14/1998SE |
| K973656 | Disposable Silicone Epistaxis CatheterEMX · Traditional | Specialty Surgical Products, Inc. | 11/18/1997SE |
| K973085 | Ultracell Packing with SleeveEMX · Traditional | Ultracell Medical Technologies, Inc. | 11/18/1997SE |
| K972922 | Vyker Silicone Epistaxis Catheter V-27030, Vyker Silicone Epistaxis Catheter Kit V-2703KEMX · Traditional | Interview Medical Technology Corp. | 10/08/1997SE |
More from Interview Medical Technology Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K190268 | Hydrofera Blue READY - BorderFRO · Traditional | 11/06/2019SE |
| K130670 | Hydrofera Blue Pu Bacteriostatic DressingFRO · Traditional | 01/02/2014SE |
| K023138 | Hydrofera Bacteriostatic Wound DressingFRO · Traditional | 01/17/2003SE |
| K013462 | Hydrofera Bacteriostatic Wound DressingFRO · Traditional | 01/11/2002SE |
| K974313 | Hydrofera Surgical SpearHOZ · Traditional | 03/02/1998SE |
| K974316 | Hydrofera Femoral WickEFQ · Traditional | 02/13/1998SE |
Questions and answers
When was Hydrofera Bacteristatic Nasal Dressing cleared by the FDA?
Hydrofera Bacteristatic Nasal Dressing (K983276) received a 510(k) decision of Substantially Equivalent on September 14, 1999, 362 days after the submission was received.
What is the product code of K983276?
The FDA product code is EMX – Balloon, Epistaxis, a Class I (low risk) device regulated under 21 CFR 874.4100.