510(k) K092530
- Device
- SPRYTIE, MODELS ST001, ST002 AND ST003
- Applicant
- RUSSELL B. WALTHER
- 510(k) number
- K092530
- Product code
- DZK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-04-02
- Date received
- 2009-08-18
- 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
- No
Applicant Contact#
- Contact
- RUSSELL B WALTHER
- Address
- 6026 Martel Ave. Dallas TX US 75206 75206
FDA Registration Numbers#
- 1224360
- 2183946
- 3015440604
- 3015399803
- 1220972
- 1649379
- 3008812560
- 3012447612
- 3034676720
- 3016050940
Source Documents#
Other 510(k) Records For Product Code DZK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K022821 | ARAGON WIRING SYSTEM WIRE CARTRIDGE, MODELS I0007 WIRE CARTRIDGE, 22 GAUGE, I0008 WIRE CARTRIDGE, 24 GAUGE, I0009 WIRE E | Ideatrics, Inc. | 2002-11-15 |
Legacy Summary#
summary
FDA Review#
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