SWABBABLE CAP, MODEL 60205
FDA 510(k) clearance K070163 · decided 2007-08-03
Clearance details
- K-number
- K070163
- Device name
- SWABBABLE CAP, MODEL 60205
- Applicant
- Baxa Corp.
- Decision
- Substantially Equivalent
- Date received
- 2007-01-17
- Decision date
- 2007-08-03
- Days to decision
- 198 days
- Clearance type
- Traditional
- Product code
- ODI
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Englewood, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.