MONOJECT INSULIN SYRINGE
FDA 510(k) clearance K033373 · decided 2003-11-13
Clearance details
- K-number
- K033373
- Device name
- MONOJECT INSULIN SYRINGE
- Applicant
- Tyco Healthcare
- Decision
- Substantially Equivalent
- Date received
- 2003-10-22
- Decision date
- 2003-11-13
- Days to decision
- 22 days
- Clearance type
- Special
- Product code
- FMI
- Device class
- 2
- Regulation number
- 880.5570
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Mansfield, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ReliOn Insulin syringes - 1cc, 31 G Distributed by: Can-Am Care, Corp., Alpharetta, GA recall (Z-0284-2009) | Covidien LP | 2008-11-05 |