H-H BURR HOLE CATHETER SUPPORT— 510(k) K853367
Substantially EquivalentHolter-Hausner Intl.
FDA 510(k) clearance K853367 for H-H BURR HOLE CATHETER SUPPORT, Substantially Equivalent on 1985-09-11. Applicant: Holter-Hausner Intl.. Device class: 2.
Clearance details
- Applicant
- Holter-Hausner Intl.
- Product code
- Code GXR
- Device class
- Class 2
- Regulation
- 21 CFR 882.5250
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bridgeport, PA, US
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