ULTRASAFE DENTAL INJECTION SYSTEM
FDA 510(k) clearance K013801 · decided 2001-12-13
Clearance details
- K-number
- K013801
- Device name
- ULTRASAFE DENTAL INJECTION SYSTEM
- Applicant
- Safety Syringes, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-11-15
- Decision date
- 2001-12-13
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- MEG
- Device class
- 2
- Regulation number
- 880.5860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Carlsbad, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| UltraSafe Dental Needle Guard, P/N: 401801 Lot:T20201501 recall (Z-0444-03) | Safety Syringes Inc | 2003-01-14 |