PRIMARY SOLUTION SET WITH UNIVERSAL SPIKE, INJECTION SITE AND MALE LUER LOCK
FDA 510(k) clearance K011336 · decided 2001-06-12
Clearance details
- K-number
- K011336
- Device name
- PRIMARY SOLUTION SET WITH UNIVERSAL SPIKE, INJECTION SITE AND MALE LUER LOCK
- Applicant
- Churchill Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-05-02
- Decision date
- 2001-06-12
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Dover, NH, US
- Third-party review
- No
- Expedited review
- No
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