510(k) K010303
- Device
- ARTSCAN CARTILAGE STIFFNESS TESTING DEVICE
- Applicant
- Artscan Medical Innovations
- 510(k) number
- K010303
- Product code
- NGR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-09-11
- Date received
- 2000-12-05
- 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
- ROBERT ANTHONY
- Address
- 4804 Oin Oak Rd. Akron OH US 44333 44333
Source Documents#
Other 510(k) Records For Product Code NGR#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K013429 | ACTAEON PROBE | Osteobiologics, Inc. | 2002-01-11 |