Product code FPY
- Device name
- Sheet, Burn
- Medical specialty
- General Hospital
- Device class
- 1
- Regulation number
- 880.5180
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K930759 | CP & S STERILE BURN SHEET | Consolidated Products & Services, Inc. | 1994-01-21 |
| K926290 | BURN SHEET | Gam Industries, Inc. | 1993-04-20 |
| K921471 | BURNSHIELD TRAUMA DRESSING | Levtrade Intl. (Pty) , Ltd. | 1993-04-20 |
| K921470 | BURNSHIELD FIRE BLANKET | Levtrade Intl. (Pty) , Ltd. | 1993-04-20 |
| K900443 | BURNS CASUALTY SHEET LIMB WRAP | Pilgrim Medical Services | 1990-07-03 |
| K900442 | BURNS CASUALTY SHEET BURN ROLL | Pilgrim Medical Services | 1990-07-03 |
| K900441 | BURNS CASUALTY SHEET | Pilgrim Medical Services | 1990-07-03 |
| K871740 | LYOSHEET SURGICAL SHEET FOR BURNS | Acme United Corp. | 1987-06-09 |
| K853145 | KENDALL CURITY BURN PAD | The Kendal Co. | 1985-08-30 |
| K841898 | FIRST RESPONSE EMERG. MEDICSL - BURNS | Reed Products, Inc. | 1984-08-14 |
| K820994 | ABSORB FURN SHEET | American Convertors Div., American Pharmaseal | 1982-05-13 |
| K800064 | WATER JEL FIRE BLANKET | Trilling Resources, Ltd. | 1980-03-25 |
| K792433 | TEMPORARY BURN SHEET WITH PERFORATED | American Medical Disposable, Inc. | 1979-12-20 |
| K792432 | TEMPORARY BURN SHEET WITH PERFORATED | American Medical Disposable, Inc. | 1979-12-20 |
| K780418 | BURN DRESSING PAD | The Owenby Co. | 1978-04-10 |
| K760210 | BLANKET, WATER-JEL FIRE | American Safety | 1976-08-11 |
| K760365 | BLANKET, BURN | Winn Hirsch & Assoc. | 1976-08-11 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10080196756544 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2025-10-22 |
| 20197344112262 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2024-11-08 |
| 00743537001439 | First Responder | WATER-JEL TECHNOLOGIES, L.L.C. | 2024-10-25 |
| 00743537000203 | First Responder | WATER-JEL TECHNOLOGIES, L.L.C. | 2024-10-25 |
| 00743537000197 | First Responder | WATER-JEL TECHNOLOGIES, L.L.C. | 2024-10-25 |
| 00743537000166 | First Responder | WATER-JEL TECHNOLOGIES, L.L.C. | 2024-10-25 |
| 00743537000067 | First Responder | WATER-JEL TECHNOLOGIES, L.L.C. | 2024-10-25 |
| 00743537000074 | First Responder | WATER-JEL TECHNOLOGIES, L.L.C. | 2024-10-25 |
| 00743537000081 | First Responder | WATER-JEL TECHNOLOGIES, L.L.C. | 2024-10-25 |
| 00743537000128 | First Responder | WATER-JEL TECHNOLOGIES, L.L.C. | 2024-10-25 |
| 00743537000135 | First Responder | WATER-JEL TECHNOLOGIES, L.L.C. | 2024-10-25 |
| 10850053289528 | SURGYCO | Surgyco LLC | 2024-08-09 |
| 10850053289610 | SURGYCO | Surgyco LLC | 2024-08-09 |
| 10850053289603 | SURGYCO | Surgyco LLC | 2024-08-09 |
| 10850053289597 | SURGYCO | Surgyco LLC | 2024-08-09 |
| 00749756337748 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2023-02-01 |
| 00749756148504 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2023-02-01 |
| 00749756045124 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2023-02-01 |
| 00749756040532 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2023-02-01 |
| 00749756040518 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2023-02-01 |
| 00749756040501 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2023-02-01 |
| 00749756040495 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2023-02-01 |
| 00749756040488 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2023-02-01 |
| 00749756040471 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2023-02-01 |
| 00749756038911 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2023-02-01 |
| 00749756032773 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2023-01-30 |
| 00749756032766 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2023-01-30 |
| 00749756032636 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2023-01-30 |
| 00749756032629 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2023-01-30 |
| 00015961293002 | ASSIST Absorbent | MILLIKEN HEALTHCARE PDTS, LLC | 2021-02-02 |