510(k) K022821
- Device
- ARAGON WIRING SYSTEM WIRE CARTRIDGE, MODELS I0007 WIRE CARTRIDGE, 22 GAUGE, I0008 WIRE CARTRIDGE, 24 GAUGE, I0009 WIRE E
- Applicant
- Ideatrics, Inc.
- 510(k) number
- K022821
- Product code
- DZK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-11-15
- Date received
- 2002-08-26
- Regulation
- 872.4880
- Classification name
- Wire, Fixation, Intraosseous
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- JAMES W HELLER
- Address
- 7341 S. Meadow Ct. Boulder CO US 80301 80301
FDA Registration Numbers#
- 3008812560
- 3012447612
- 3016050940
- 1220972
- 1224360
- 2183946
- 3015399803
- 3034676720
- 1649379
- 3015440604
Source Documents#
Other 510(k) Records For Product Code DZK#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K092530 | SPRYTIE, MODELS ST001, ST002 AND ST003 | Russell B. Walther | 2010-04-02 |