FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EXAPHASE, SINGLE PHASE IMPRESSION MATERIAL
K Number: K902531
·
Decision Jul 13, 1990
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
1
Applicant Total
23
Review Days
38
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Basic Information
- Device Name
- EXAPHASE, SINGLE PHASE IMPRESSION MATERIAL
- K Number
- K902531
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1900
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- G-C Intl. Corp.
- Date Received
- June 5, 1990
- Decision Date
- July 13, 1990
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EGW), ordered by most recent decision date.
View allOther Clearances by G-C Intl. Corp.
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