Trach Cleaning Tray
FDA 510(k) K811990 · Associated Medical Products Co.
510(k) numberK811990
Submission
- Device name
- Trach Cleaning Tray
- Applicant
- Associated Medical Products Co.
Mchenry, IL, US - Received
- July 13, 1981
- Decision date
- July 27, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FRL – Fiber, Medical, Absorbent
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5300
- Specialty
- General Hospital
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| K061615 | Interdry Textile with SilverFRL · Traditional | Milliken Chemical | 12/22/2006SE |
| K931626 | Carapace Sterile Cotton BallsFRL · Traditional | Carapace, Inc. | 12/02/1993SE |
| K914081 | Ican Cotton Rayon BallsFRL · Traditional | Icn Pharmaceuticals, Inc. | 10/09/1991SE |
| K810242 | Utensil & Procedure TraysFRL · Traditional | American Hospital Supply Corp. | 04/15/1981SE |
| K800277 | Medspec Rayon BallsFRL · Traditional | Medspec Corp. | 03/12/1980SE |
| K800249 | Surgitek Foerster Mammary BandageFRL · Traditional | Medical Engineering Corp. | 02/19/1980SE |
| K800248 | Surgitek Foerster Face Lift BandageFRL · Traditional | Medical Engineering Corp. | 02/19/1980SE |
| K792295 | SorbiesFRL · Traditional | American Hospital Supply Corp. | 12/20/1979SE |
More from American Hospital Supply Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K932221 | Neurological or Crani Trays (Packs)LRO · Traditional | 03/19/1997SE |
| K932216 | C-Section, Labor & Delivery Trays (Packs)MLS · Traditional | 04/19/1994SESK |
| K930507 | Custom Orthopaedic Trays (Packs)HTS · Traditional | 02/22/1994SE |
| K932217 | Major, Minor, Basin Trays (Packs)LRO · Traditional | 11/15/1993SESK |
| K932220 | Lap Choly Trays (Packs)LRO · Traditional | 09/27/1993SESK |
| K932218 | Cardiac Cath or Angiographic TraysDQO · Traditional | 08/27/1993SEKD |
| K932219 | Suture Set or Laceration Trays (Packs)KDD · Traditional | 07/09/1993SESK |
| K842983 | Ampco Opthalmic TrayHOZ · Traditional | 05/22/1985SE |
| K843114 | Ampco Procedure Trays / Packs · Traditional | 08/08/1984SESP |
| K823839 | Ampco Kidney Dialysis TrayKOC · Traditional | 03/29/1983SE |
Questions and answers
When was Trach Cleaning Tray cleared by the FDA?
Trach Cleaning Tray (K811990) received a 510(k) decision of Substantially Equivalent on July 27, 1981, 14 days after the submission was received.
What is the product code of K811990?
The FDA product code is FRL – Fiber, Medical, Absorbent, a Class I (low risk) device regulated under 21 CFR 880.5300.