Temporary Burn Sheet with Perforated
FDA 510(k) K792432 · American Medical Disposable, Inc.
510(k) numberK792432
Submission
- Device name
- Temporary Burn Sheet with Perforated
- Applicant
- American Medical Disposable, Inc.
Walker, MI, US - Received
- November 28, 1979
- Decision date
- December 20, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FPY – Sheet, Burn
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5180
- Specialty
- General Hospital
Other 510(k)s with product code FPY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K930759 | CP & S Sterile Burn SheetFPY · Traditional | Consolidated Products & Services, Inc. | 01/21/1994SE |
| K926290 | Burn SheetFPY · Traditional | Gam Industries, Inc. | 04/20/1993SE |
| K921471 | Burnshield Trauma DressingFPY · Traditional | Levtrade Intl. (Pty) , Ltd. | 04/20/1993SE |
| K921470 | Burnshield Fire BlanketFPY · Traditional | Levtrade Intl. (Pty) , Ltd. | 04/20/1993SE |
| K900443 | Burns Casualty Sheet Limb WrapFPY · Traditional | Pilgrim Medical Services | 07/03/1990SE |
| K900442 | Burns Casualty Sheet Burn RollFPY · Traditional | Pilgrim Medical Services | 07/03/1990SE |
| K900441 | Burns Casualty SheetFPY · Traditional | Pilgrim Medical Services | 07/03/1990SE |
| K871740 | Lyosheet Surgical Sheet for BurnsFPY · Traditional | Acme United Corp. | 06/09/1987SE |
| K853145 | Kendall Curity Burn PadFPY · Traditional | The Kendal Co. | 08/30/1985SN |
| K841898 | First Response Emerg. Medicsl - BurnsFPY · Traditional | Reed Products, Inc. | 08/14/1984SE |
More from Reed Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K833735 | An Odor Absorbent BandageNAB · Traditional | 04/23/1984SE |
| K833734 | Neurological Sponge on Plastic Stick · Traditional | 04/23/1984SE |
| K833731 | Breathable Overwray Bandage Non-ElasKGX · Traditional | 01/27/1984SE |
| K833730 | Non Adherent Bandage/SheetFRO · Traditional | 01/27/1984SE |
| K833729 | Elastic Breathable Over-Wrap BandageNAD · Traditional | 12/30/1983SE |
| K833733 | Non - Adherent BandageFRO · Traditional | 12/27/1983SE |
| K833732 | Non Wetting Undercast PaddingITG · Traditional | 12/12/1983SE |
| K830202 | Cotton Balls, X-Ray Opaqued Strung & NonGDY · Traditional | 02/23/1983SE |
| K830201 | Polyester X-Ray Detectable Strung-SpongeGDY · Traditional | 02/23/1983SE |
| K803116 | Heavy Drainage PackGEC · Traditional | 01/28/1981SE |
Questions and answers
When was Temporary Burn Sheet with Perforated cleared by the FDA?
Temporary Burn Sheet with Perforated (K792432) received a 510(k) decision of Substantially Equivalent on December 20, 1979, 22 days after the submission was received.
What is the product code of K792432?
The FDA product code is FPY – Sheet, Burn, a Class I (low risk) device regulated under 21 CFR 880.5180.