510(k) K032388
- Device
- BONE CEMENT RADIO-OPACIFIER
- Applicant
- Cardinal Health
- 510(k) number
- K032388
- Product code
- MYU
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-10-31
- Date received
- 2003-08-04
- Regulation
- 882.5300
- Classification name
- Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- SHARON NICHOLS
- Address
- 1500 Waukegan Rd. Waukegan IL US 60085 60085
FDA Registration Numbers#
- 2031093
Source Documents#
Other 510(k) Records For Product Code MYU #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K033230 | TRACERS TA BONE CEMENT OPACIFIER, MODEL TCR-TA | Parallax Medical, Inc. | 2003-12-12 |
| K024359 | VISTA SCIENTIFIC BARIUM SULFATE, MODEL 3001-1 | Vista Scientific, LLC | 2003-08-08 |
| K023445 | TRACERS BONE CEMENT OPACIFIER | Parallax Medical, Inc. | 2003-03-11 |
| K002063 | BIOTRACE, MODEL 1730 | Bryan Corp. | 2000-08-10 |
| K991893 | PARALLAX TRACER RADIOPAQUE PARTICLES | Parallax Medical, Inc. | 1999-08-13 |
Legacy Summary#
summary
FDA Review#
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