CLAVE STOPCOCK
FDA 510(k) clearance K080077 · decided 2008-02-13
Clearance details
- K-number
- K080077
- Device name
- CLAVE STOPCOCK
- Applicant
- Icu Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-01-11
- Decision date
- 2008-02-13
- Days to decision
- 33 days
- Clearance type
- Traditional
- Product code
- FMG
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.