EXAPHASE, SINGLE PHASE IMPRESSION MATERIAL
FDA 510(k) clearance K902531 · decided 1990-07-13
Clearance details
- K-number
- K902531
- Device name
- EXAPHASE, SINGLE PHASE IMPRESSION MATERIAL
- Applicant
- G-C Intl. Corp.
- Decision
- Substantially Equivalent
- Date received
- 1990-06-05
- Decision date
- 1990-07-13
- Days to decision
- 38 days
- Clearance type
- Traditional
- Product code
- EGW
- Device class
- 2
- Regulation number
- 892.1900
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Scottsdale, AZ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PAKOSTAT II (K760846) | Pako Corp. | 1977-01-07 |
Recalls involving this device
No recalls on record reference this clearance.