MANUAL BONE MARROW BIOPSY DEVICE
FDA 510(k) clearance K993435 · decided 1999-12-06
Clearance details
- K-number
- K993435
- Device name
- MANUAL BONE MARROW BIOPSY DEVICE
- Applicant
- Promex, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-10-12
- Decision date
- 1999-12-06
- Days to decision
- 55 days
- Clearance type
- Traditional
- Product code
- KNW
- Device class
- 2
- Regulation number
- 876.1075
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Franklin, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Bone Marrow Aspiration Kit, consists of 3 main components packaged in a box. 1. Marrow Loc recall (Z-0272-2009) | Theken Spine LLC | 2008-11-18 |