Burn Dressing Pad
FDA 510(k) K780418 · The Owenby Co.
510(k) numberK780418
Submission
- Device name
- Burn Dressing Pad
- Applicant
- The Owenby Co.
Mchenry, IL, US - Received
- March 14, 1978
- Decision date
- April 10, 1978
- 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 |
|---|---|---|
| K801628 | Restraint, ProtectiveIQK · Traditional | 08/07/1980SE |
| K801627 | Cover, LimbIPM · Traditional | 07/28/1980SE |
| K801626 | Arm SlingILI · Traditional | 07/28/1980SE |
| K801532 | Stockinette, Sterile Two Ply W/Pull TabsFQM · Traditional | 07/28/1980SE |
| K801531 | Arm SlingILI · Traditional | 07/21/1980SE |
| K790210 | Stockinette, Tubular UnbleachedFQM · Traditional | 02/27/1979SE |
| K780764 | Non-Sterile Folded GauzeNAB · Traditional | 06/06/1978SE |
| K770889 | Burn Dressing KitEFQ · Traditional | 07/11/1977SE |
| K761071 | P.S.M. Justa KapFYF · Traditional | 12/30/1976SE |
| K761070 | P.S.M. Surgical HoodFXY · Traditional | 12/30/1976SE |
Questions and answers
When was Burn Dressing Pad cleared by the FDA?
Burn Dressing Pad (K780418) received a 510(k) decision of Substantially Equivalent on April 10, 1978, 27 days after the submission was received.
What is the product code of K780418?
The FDA product code is FPY – Sheet, Burn, a Class I (low risk) device regulated under 21 CFR 880.5180.