Skin Scrub-Tray
FDA 510(k) K821579 · Associated Medical Products Co.
510(k) numberK821579
Submission
- Device name
- Skin Scrub-Tray
- Applicant
- Associated Medical Products Co.
Mchenry, IL, US - Received
- May 28, 1982
- Decision date
- July 21, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LDR – Controller, Infusion, Intravascular, Electronic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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| K934543 | Universal Controller, Model 100LDR · Traditional | Metamed, Inc. | 03/29/1994SE |
| K935236 | Flow Controlling Extension SetLDR · Traditional | Block Medical, Inc. | 02/24/1994SE |
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More from The Master Medical 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 Skin Scrub-Tray cleared by the FDA?
Skin Scrub-Tray (K821579) received a 510(k) decision of Substantially Equivalent on July 21, 1982, 54 days after the submission was received.
What is the product code of K821579?
The FDA product code is LDR – Controller, Infusion, Intravascular, Electronic, a Class II (moderate risk) device regulated under 21 CFR 880.5725.