FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FLOUROSHIELD RADIATION REDUCTION GLOVE
K Number: K893093
·
Decision Feb 13, 1990
Classifications
1
FEI Numbers
269
Registration Numbers
269
Same Product Code
78
Applicant Total
78
Review Days
306
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Basic Information
- Device Name
- FLOUROSHIELD RADIATION REDUCTION GLOVE
- K Number
- K893093
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Acufex Microsurgical, Inc.
- Date Received
- April 13, 1989
- Decision Date
- February 13, 1990
- Product Code
- LZC
- 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 |
|---|---|---|---|
| LZC | Medical Glove, Specialty | FDA class 1 | General Hospital |
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