PAKOSTAT II
FDA 510(k) clearance K760846 · decided 1977-01-07
Clearance details
- K-number
- K760846
- Device name
- PAKOSTAT II
- Applicant
- Pako Corp.
- Decision
- Substantially Equivalent
- Date received
- 1976-10-15
- Decision date
- 1977-01-07
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- EGW
- Device class
- 2
- Regulation number
- 892.1900
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Pako Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| EXAPHASE, SINGLE PHASE IMPRESSION MATERIAL (K902531) | G-C Intl. Corp. | 1990-07-13 |
Recalls involving this device
No recalls on record reference this clearance.