ONE-PIECE SHUNT
FDA 510(k) clearance K834593 · decided 1984-04-03
Clearance details
- K-number
- K834593
- Device name
- ONE-PIECE SHUNT
- Applicant
- American Heyer Schulte
- Decision
- Substantially Equivalent
- Date received
- 1983-12-29
- Decision date
- 1984-04-03
- Days to decision
- 96 days
- Clearance type
- Traditional
- Product code
- JXG
- Device class
- 2
- Regulation number
- 882.5550
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.