SET, ADMINISTRATION INTRAVASCULAR
FDA 510(k) clearance K874467 · decided 1988-01-06
Clearance details
- K-number
- K874467
- Device name
- SET, ADMINISTRATION INTRAVASCULAR
- Applicant
- Kendall Mcgaw Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-11-02
- Decision date
- 1988-01-06
- Days to decision
- 65 days
- Clearance type
- Traditional
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Santa Ana, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.