SWABCAP AND SWABFLUSH
FDA 510(k) clearance K130975 · decided 2013-12-24
Clearance details
- K-number
- K130975
- Device name
- SWABCAP AND SWABFLUSH
- Applicant
- Excelsior Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 2013-04-08
- Decision date
- 2013-12-24
- Days to decision
- 260 days
- Clearance type
- Traditional
- Product code
- QBP
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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