510(k) K760846
- Device
- PAKOSTAT II
- Applicant
- PAKO CORP.
- 510(k) number
- K760846
- Product code
- EGW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-01-07
- Date received
- 1976-10-15
- 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#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EGW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K902531 | EXAPHASE, SINGLE PHASE IMPRESSION MATERIAL | G-C Intl. Corp. | 1990-07-13 |
Legacy Summary#
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FDA Review#
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