SPRYTIE, MODELS ST001, ST002 AND ST003
FDA 510(k) clearance K092530 · decided 2010-04-02
Clearance details
- K-number
- K092530
- Device name
- SPRYTIE, MODELS ST001, ST002 AND ST003
- Applicant
- Russell B. Walther
- Decision
- Substantially Equivalent
- Date received
- 2009-08-18
- Decision date
- 2010-04-02
- Days to decision
- 227 days
- Clearance type
- Traditional
- Product code
- DZK
- Device class
- 2
- Regulation number
- 872.4880
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Dallas, TX, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ARAGON WIRING SYSTEM WIRE CARTRIDGE, MODELS I0007 WIRE CARTRIDGE, 22 GAUGE, I0008 WIRE CARTRIDGE, 24 GAUGE, I0009 WIRE E (K022821) | Ideatrics, Inc. | 2002-11-15 |
Recalls involving this device
No recalls on record reference this clearance.