SIDEKICK INFUSION KIT
FDA 510(k) clearance K990425 · decided 1999-04-23
Clearance details
- K-number
- K990425
- Device name
- SIDEKICK INFUSION KIT
- Applicant
- I-Flow Corp.
- Decision
- Substantially Equivalent
- Date received
- 1999-02-11
- Decision date
- 1999-04-23
- Days to decision
- 71 days
- Clearance type
- Traditional
- Product code
- FRN
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Lake Forest, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.