AOC BONE WAX
FDA 510(k) clearance K041363 · decided 2004-07-27
Clearance details
- K-number
- K041363
- Device name
- AOC BONE WAX
- Applicant
- Ceremed , Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-05-21
- Decision date
- 2004-07-27
- Days to decision
- 67 days
- Clearance type
- Traditional
- Product code
- MTJ
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Los Angeles, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Baxter Ostene Hemostasis Material, Product Codes: a) 1503831, 3.5 G; b) 1503832, 2.5 G; c) recall (Z-0658-2024) | Baxter Healthcare Corporation | 2024-01-05 |