WRIGHT CARE
FDA 510(k) clearance K823497 · decided 1983-01-07
Clearance details
- K-number
- K823497
- Device name
- WRIGHT CARE
- Applicant
- Dow Corning Wright
- Decision
- Substantially Equivalent
- Date received
- 1982-11-23
- Decision date
- 1983-01-07
- Days to decision
- 45 days
- Clearance type
- Traditional
- Product code
- GZJ
- Device class
- 2
- Regulation number
- 882.5890
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Mchenry, IL, 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.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| WHITESIDE EPS(TM) FEMORAL HIP PROSTHESIS (P880076/S001) | Dow Corning Wright | 1991-06-17 |