PGK STEREOTACTIC DEVICE
FDA 510(k) clearance K911974 · decided 1991-11-05
Clearance details
- K-number
- K911974
- Device name
- PGK STEREOTACTIC DEVICE
- Applicant
- Northern Virginia Radiology and Nuclear Medicine
- Decision
- Substantially Equivalent
- Date received
- 1991-05-03
- Decision date
- 1991-11-05
- Days to decision
- 186 days
- Clearance type
- Traditional
- Product code
- HRX
- Device class
- 2
- Regulation number
- 888.1100
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Falls Church, VA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.