CP & S Sterile Burn Sheet
FDA 510(k) K930759 · Consolidated Products & Services, Inc.
510(k) numberK930759
Submission
- Device name
- CP & S Sterile Burn Sheet
- Applicant
- Consolidated Products & Services, Inc.
North Quincy, MA, US - Received
- February 12, 1993
- Decision date
- January 21, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|---|
| 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 |
| K820994 | Absorb Furn SheetFPY · Traditional | American Convertors Div., American Pharmaseal | 05/13/1982SE |
More from American Convertors Div., American Pharmaseal
| 510(k) | Device | Decision |
|---|---|---|
| K974190 | Cp&S Instant Cold Pack Limb Kit TransporterIMD · Traditional | 11/19/1997SE |
| K890551 | Urinary Drainage UnitKNX · Traditional | 02/28/1989SE |
| K890550 | Cp&S Disposable Urinary Legbag (Medium & Large)KNX · Traditional | 02/28/1989SE |
| K890552 | Cp&S Gavage Constainer, DisposableKNT · Traditional | 02/24/1989SE |
| K890554 | Cp&S Disposable Instant Super Hot CompressIMD · Traditional | 02/13/1989SE |
| K890553 | Cp&S Disposable Instant Cold CompressIMD · Traditional | 02/13/1989SE |
Questions and answers
When was CP & S Sterile Burn Sheet cleared by the FDA?
CP & S Sterile Burn Sheet (K930759) received a 510(k) decision of Substantially Equivalent on January 21, 1994, 343 days after the submission was received.
What is the product code of K930759?
The FDA product code is FPY – Sheet, Burn, a Class I (low risk) device regulated under 21 CFR 880.5180.