510(k) K013429
- Device
- ACTAEON PROBE
- Applicant
- Osteobiologics, Inc.
- 510(k) number
- K013429
- Product code
- NGR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-01-11
- Date received
- 2001-10-16
- Regulation
- 888.1100
- Classification name
- Tester, Stiffness, Cartilage, Arthroscopic
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- MARK Q NIEDERAUER
- Address
- University Business Park 12500 Network, Suite 112 San Antonio TX US 78249 78249
Source Documents#
Other 510(k) Records For Product Code NGR#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K010303 | ARTSCAN CARTILAGE STIFFNESS TESTING DEVICE | Artscan Medical Innovations | 2001-09-11 |