HALF ROUND FILE
FDA 510(k) clearance K840980 · decided 1984-04-25
Clearance details
- K-number
- K840980
- Device name
- HALF ROUND FILE
- Applicant
- Med-Tool, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-03-06
- Decision date
- 1984-04-25
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- HTC
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- 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 |
|---|---|---|
| SIDE CUTTING PARALLEL ACTION PLIERS (K872384) | Med-Tool, Inc. | 1987-07-02 |
| NEEDLE NOSE PLIERS (K864019) | Med-Tool, Inc. | 1986-10-30 |
| PARALLEL ACTION PLIERS (K861953) | Med-Tool, Inc. | 1986-06-06 |
| WIRE CUTTING PLIERS OR LINEMAN'S PLIERS (K854390) | Med-Tool, Inc. | 1985-11-19 |
| SLIP JOINT PLIERS (K844600) | Med-Tool, Inc. | 1984-12-14 |
| TOGGLE LOCKING PLIERS-STRAIGHT JAW, CURVED JAW (K844146) | Med-Tool, Inc. | 1984-11-20 |
| SLIP JOINT PLIER (K840979) | Med-Tool, Inc. | 1984-04-25 |
| TOGGLE LOCKING PLIER (K840978) | Med-Tool, Inc. | 1984-04-25 |
| WIRE TWISTERS (K830721) | The Anspach Effort, Inc. | 1983-04-12 |
Recalls involving this device
No recalls on record reference this clearance.