INSIDE JOB
FDA 510(k) clearance K912871 · decided 1991-08-09
Clearance details
- K-number
- K912871
- Device name
- INSIDE JOB
- Applicant
- 3M Health Care, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1991-06-28
- Decision date
- 1991-08-09
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- HRX
- Device class
- 2
- Regulation number
- 888.1100
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- St. Paul, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| MicroAire SmartRelease Endoscopic System, Endoscopic Carpal Tunnel Release, SmartRelease H recall (Z-2107-2018) | MicroAire Surgical Instruments, LLC | 2018-05-25 |