Burns Casualty Sheet Burn Roll
FDA 510(k) K900442 · Pilgrim Medical Services
510(k) numberK900442
Submission
- Device name
- Burns Casualty Sheet Burn Roll
- Applicant
- Pilgrim Medical Services
England Hr2 6sx, GB - Received
- January 30, 1990
- Decision date
- July 3, 1990
- 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 |
| 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 |
| K820994 | Absorb Furn SheetFPY · Traditional | American Convertors Div., American Pharmaseal | 05/13/1982SE |
More from American Convertors Div., American Pharmaseal
Questions and answers
When was Burns Casualty Sheet Burn Roll cleared by the FDA?
Burns Casualty Sheet Burn Roll (K900442) received a 510(k) decision of Substantially Equivalent on July 3, 1990, 154 days after the submission was received.
What is the product code of K900442?
The FDA product code is FPY – Sheet, Burn, a Class I (low risk) device regulated under 21 CFR 880.5180.