UNICUFF
FDA 510(k) clearance K812639 · decided 1981-10-02
Clearance details
- K-number
- K812639
- Device name
- UNICUFF
- Applicant
- Frontier Products
- Decision
- Substantially Equivalent
- Date received
- 1981-09-16
- Decision date
- 1981-10-02
- Days to decision
- 16 days
- Clearance type
- Traditional
- Product code
- DXP
- Device class
- 2
- Regulation number
- 870.2890
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- 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.
| Record | Firm | Date |
|---|---|---|
| TRANSESOPHAGEAL ULTRASOUND ACCESSORIES KIT (K891180) | Ingress Technologies, Inc. | 1989-06-15 |
Recalls involving this device
No recalls on record reference this clearance.