FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PAKOSTAT II
K Number: K760846
·
Decision Jan 7, 1977
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
1
Applicant Total
1
Review Days
84
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Basic Information
- Device Name
- PAKOSTAT II
- K Number
- K760846
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1900
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Pako Corp.
- Date Received
- October 15, 1976
- Decision Date
- January 7, 1977
- Product Code
- EGW
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| EGW | Dryer, Film, Radiographic | FDA class 2 | Radiology |
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