EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825
FDA 510(k) clearance K031571 · decided 2003-06-19
Clearance details
- K-number
- K031571
- Device name
- EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825
- Applicant
- E-Z-Em, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-05-20
- Decision date
- 2003-06-19
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- IZQ
- Device class
- 2
- Regulation number
- 870.1650
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Westbury, NY, US
- Third-party review
- No
- Expedited review
- No
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