MODIFIED HC-417 BAG TO BAG & HC-418 BOTTLE TO BAG
FDA 510(k) clearance K861434 · decided 1986-05-01
Clearance details
- K-number
- K861434
- Device name
- MODIFIED HC-417 BAG TO BAG & HC-418 BOTTLE TO BAG
- Applicant
- Churchill Corp.
- Decision
- Substantially Equivalent
- Date received
- 1986-04-17
- Decision date
- 1986-05-01
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- LHI
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Langhorne, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.