BURN DRESSING PAD
FDA 510(k) clearance K780418 · decided 1978-04-10
Clearance details
- K-number
- K780418
- Device name
- BURN DRESSING PAD
- Applicant
- The Owenby Co.
- Decision
- Substantially Equivalent
- Date received
- 1978-03-14
- Decision date
- 1978-04-10
- Days to decision
- 27 days
- Clearance type
- Traditional
- Product code
- FPY
- Device class
- 1
- Regulation number
- 880.5180
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CP & S STERILE BURN SHEET (K930759) | Consolidated Products & Services, Inc. | 1994-01-21 |
| BURNSHIELD FIRE BLANKET (K921470) | Levtrade Intl. (Pty) , Ltd. | 1993-04-20 |
| BURNSHIELD TRAUMA DRESSING (K921471) | Levtrade Intl. (Pty) , Ltd. | 1993-04-20 |
| BURN SHEET (K926290) | Gam Industries, Inc. | 1993-04-20 |
| BURNS CASUALTY SHEET LIMB WRAP (K900443) | Pilgrim Medical Services | 1990-07-03 |
| BURNS CASUALTY SHEET BURN ROLL (K900442) | Pilgrim Medical Services | 1990-07-03 |
| BURNS CASUALTY SHEET (K900441) | Pilgrim Medical Services | 1990-07-03 |
| LYOSHEET SURGICAL SHEET FOR BURNS (K871740) | Acme United Corp. | 1987-06-09 |
| KENDALL CURITY BURN PAD (K853145) | The Kendal Co. | 1985-08-30 |
| FIRST RESPONSE EMERG. MEDICSL - BURNS (K841898) | Reed Products, Inc. | 1984-08-14 |
| ABSORB FURN SHEET (K820994) | American Convertors Div., American Pharmaseal | 1982-05-13 |
| WATER JEL FIRE BLANKET (K800064) | Trilling Resources, Ltd. | 1980-03-25 |
Recalls involving this device
No recalls on record reference this clearance.