PANAG
FDA 510(k) clearance K011891 · decided 2002-07-30
Clearance details
- K-number
- K011891
- Device name
- PANAG
- Applicant
- Panag International
- Decision
- Substantially Equivalent
- Date received
- 2001-06-18
- Decision date
- 2002-07-30
- Days to decision
- 407 days
- Clearance type
- Traditional
- Product code
- GZJ
- Device class
- 2
- Regulation number
- 882.5890
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Johannesburg, ZA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.