Lyosheet Surgical Sheet for Burns
FDA 510(k) K871740 · Acme United Corp.
510(k) numberK871740
Submission
- Device name
- Lyosheet Surgical Sheet for Burns
- Applicant
- Acme United Corp.
Fairfield, CT, US - Received
- May 5, 1987
- Decision date
- June 9, 1987
- 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 |
| 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 |
| K820994 | Absorb Furn SheetFPY · Traditional | American Convertors Div., American Pharmaseal | 05/13/1982SE |
More from American Convertors Div., American Pharmaseal
| 510(k) | Device | Decision |
|---|---|---|
| K961323 | Lyofoam Extra C Odor Absorbing Wound DressingKMF · Traditional | 06/19/1996SE |
| K961452 | Lyofoam Extra 'A' Sterile Adhesive Wound DressingKMF · Traditional | 05/31/1996SE |
| K952565 | Lyofoam ExtraKMF · Traditional | 11/14/1995SN |
| K895764 | Modified Lyofoam Wound DressingsKMF · Traditional | 09/10/1990SN |
| K864084 | Lyofoam C Odor-Absorbing DressingFRO · Traditional | 11/21/1986SN |
| K860085 | Lyofoam Wound DressingsNAD · Traditional | 06/27/1986SN |
| K860818 | One Time Enteral Feeding BagKNT · Traditional | 05/15/1986SE |
| K861015 | One Time Hyperal & Catheter Dressing Change TraysFOZ · Traditional | 04/22/1986SE |
| K842186 | Acu-Derm Transparent Wound DressingNAD · Traditional | 08/24/1984SE |
| K842064 | Acu-Derm Transparent IV DressingKMK · Traditional | 08/15/1984SE |
Questions and answers
When was Lyosheet Surgical Sheet for Burns cleared by the FDA?
Lyosheet Surgical Sheet for Burns (K871740) received a 510(k) decision of Substantially Equivalent on June 9, 1987, 35 days after the submission was received.
What is the product code of K871740?
The FDA product code is FPY – Sheet, Burn, a Class I (low risk) device regulated under 21 CFR 880.5180.