FDA 510(k)
FDA class 1
Unknown
🇺🇸 United States
DRESSING CHANGE KIT
K Number: K914927
·
Decision Jan 31, 1992
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
1953
Applicant Total
7
Review Days
88
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Basic Information
- Device Name
- DRESSING CHANGE KIT
- K Number
- K914927
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- Westmark Hospital Supplies
- Date Received
- November 4, 1991
- Decision Date
- January 31, 1992
- Product Code
- LYY
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| LYY | Latex Patient Examination Glove | FDA class 1 | General Hospital |
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