510(k) K902531
- Device
- EXAPHASE, SINGLE PHASE IMPRESSION MATERIAL
- Applicant
- G-C INTL. CORP.
- 510(k) number
- K902531
- Product code
- EGW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-07-13
- Date received
- 1990-06-05
- Regulation
- 892.1900
- Classification name
- Dryer, Film, Radiographic
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- WILLIAM R JACOBS
- Address
- 7830 E.Redfield Rd. Suite 12 (Gc Tells Of Firm Closing) Scottsdale AZ US 85260 85260
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EGW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K760846 | PAKOSTAT II | Pako Corp. | 1977-01-07 |
Legacy Summary#
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FDA Review#
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