NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER WITH POSIFLOW POSITIVE DISPLACEMENT FEATURE, AND I.V. SETS
FDA 510(k) clearance K964918 · decided 1997-04-14
Clearance details
- K-number
- K964918
- Device name
- NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER WITH POSIFLOW POSITIVE DISPLACEMENT FEATURE, AND I.V. SETS
- Applicant
- Critical Device Corp.
- Decision
- Substantially Equivalent
- Date received
- 1996-12-09
- Decision date
- 1997-04-14
- Days to decision
- 126 days
- Clearance type
- Traditional
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Brea, CA, US
- Third-party review
- No
- Expedited review
- No
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