SAFE-CONNECT VIAL DISPENSING SPIKE
FDA 510(k) clearance K970789 · decided 1997-05-01
Clearance details
- K-number
- K970789
- Device name
- SAFE-CONNECT VIAL DISPENSING SPIKE
- Applicant
- Faulding Medical Device Co.
- Decision
- Substantially Equivalent
- Date received
- 1997-03-04
- Decision date
- 1997-05-01
- Days to decision
- 58 days
- Clearance type
- Traditional
- Product code
- LHI
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Scottsdale, AZ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.