FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FIBER HEMOFILTERS FH55-FH77 & 88
K Number: K840720
·
Decision Apr 24, 1984
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
47
Applicant Total
86
Review Days
67
Basic Information
- Device Name
- FIBER HEMOFILTERS FH55-FH77 & 88
- K Number
- K840720
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6080
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- GAMBRO, INC.
- Date Received
- February 17, 1984
- Decision Date
- April 24, 1984
- Product Code
- KOJ
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| KOJ | Airbrush | FDA class 2 | Dental |
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