Utensil & Procedure Trays
FDA 510(k) K810242 · American Hospital Supply Corp.
510(k) numberK810242
Submission
- Device name
- Utensil & Procedure Trays
- Applicant
- American Hospital Supply Corp.
Mchenry, IL, US - Received
- January 28, 1981
- Decision date
- April 15, 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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| K811990 | Trach Cleaning TrayFRL · Traditional | Associated Medical Products Co. | 07/27/1981SE |
| 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 |
|---|---|---|
| K854739 | American Sterile Surgical Absorbent Towel · Traditional | 12/27/1985SE |
| K854759 | American Sterile Mayo Stand Tray · Traditional | 12/17/1985SE |
| K832826 | Aap Dosimetry Release or Basin SetsFNY · Traditional | 04/23/1984SE |
| K830546 | Dosimetric ReleaseKQT · Traditional | 05/25/1983SE |
| K822990 | Convertors Primary Wound Dressing IIFRO · Traditional | 04/12/1983SE |
| K830343 | Container W/Priming SolutionKDP · Traditional | 03/17/1983SE |
| K830301 | Stratus Fluorometric Enzyme IMMUN0-JJE · Traditional | 02/25/1983SE |
| K822755 | Latex Penrose Tubing · Traditional | 01/21/1983SE |
| K823418 | Heyer-Schute Universal Ureteral StentLJE · Traditional | 12/03/1982SE |
| K822966 | Convertors Disposable Dressing SpongeNAB · Traditional | 11/05/1982SE |
Questions and answers
When was Utensil & Procedure Trays cleared by the FDA?
Utensil & Procedure Trays (K810242) received a 510(k) decision of Substantially Equivalent on April 15, 1981, 77 days after the submission was received.
What is the product code of K810242?
The FDA product code is FRL – Fiber, Medical, Absorbent, a Class I (low risk) device regulated under 21 CFR 880.5300.