FORCEPS-ORTHOPEDIC
FDA 510(k) clearance K890165 · decided 1989-02-13
Clearance details
- K-number
- K890165
- Device name
- FORCEPS-ORTHOPEDIC
- Applicant
- Dhason Brothers, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-01-09
- Decision date
- 1989-02-13
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- LXN
- Device class
- 1
- Regulation number
- 870.4500
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Hyattsville, MD, 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 |
|---|---|---|
| EDWARDS-DUROMEDICS LEAFLET PROBE, MODEL 1116 (K881449) | Baxter Healthcare Corp | 1988-06-15 |
Recalls involving this device
No recalls on record reference this clearance.