ROTATING, FIXED FOOTED, FIXED SHIELD ATTACHMENTS, DISSECTING TOOLS
FDA 510(k) clearance K953432 · decided 1995-09-14
Clearance details
- K-number
- K953432
- Device name
- ROTATING, FIXED FOOTED, FIXED SHIELD ATTACHMENTS, DISSECTING TOOLS
- Applicant
- Midas Rex Pneumatic Tools, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-07-21
- Decision date
- 1995-09-14
- Days to decision
- 55 days
- Clearance type
- Traditional
- Product code
- GET
- Device class
- 1
- Regulation number
- 878.4820
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Fort Worth, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Medtronic Midas Rex Classic, GS and Legend dissecting tools manufactured by Medtronic Inc. recall (Z-1574-05) | Power Surgical Solutions | 2005-09-21 |