TRACERS TA BONE CEMENT OPACIFIER, MODEL TCR-TA— 510(k) K033230
Substantially EquivalentParallax Medical, Inc.
FDA 510(k) clearance K033230 for TRACERS TA BONE CEMENT OPACIFIER, MODEL TCR-TA, Substantially Equivalent on 2003-12-12. Applicant: Parallax Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Parallax Medical, Inc.
- Product code
- Code MYU
- Device class
- Class 2
- Regulation
- 21 CFR 882.5300
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Scotts Valley, CA, US
Recent devices under product code MYU
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