FDA 510(k)
FDA class 1
Substantially Equivalent
🇿🇦 South Africa
BURNSHIELD TRAUMA DRESSING
K Number: K921471
·
Decision Apr 20, 1993
Classifications
1
FEI Numbers
58
Registration Numbers
58
Same Product Code
16
Applicant Total
4
Review Days
389
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- BURNSHIELD TRAUMA DRESSING
- K Number
- K921471
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5180
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Levtrade Intl. (Pty) , Ltd.
- Date Received
- March 27, 1992
- Decision Date
- April 20, 1993
- Product Code
- FPY
- Advisory Committee
- General Hospital
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FPY | Sheet, Burn | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FPY), ordered by most recent decision date.
CP & S STERILE BURN SHEET
FDA 510(k)
FDA Class 1
·General Hospital
BURNSHIELD FIRE BLANKET
FDA 510(k)
FDA Class 1
·General Hospital
BURN SHEET
FDA 510(k)
FDA Class 1
·General Hospital
BURNS CASUALTY SHEET
FDA 510(k)
FDA Class 1
·General Hospital
BURNS CASUALTY SHEET LIMB WRAP
FDA 510(k)
FDA Class 1
·General Hospital
BURNS CASUALTY SHEET BURN ROLL
FDA 510(k)
FDA Class 1
·General Hospital