LOPEZ VALVE
FDA 510(k) clearance K861586 · decided 1986-08-18
Clearance details
- K-number
- K861586
- Device name
- LOPEZ VALVE
- Applicant
- Icu Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-04-29
- Decision date
- 1986-08-18
- Days to decision
- 111 days
- Clearance type
- Traditional
- Product code
- MJF
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Huntington Beach, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.