NO. 5300-3 1/2 FRENCH UMBILICAL VESSEL CATH. ETC.
FDA 510(k) clearance K851981 · decided 1985-06-18
Clearance details
- K-number
- K851981
- Device name
- NO. 5300-3 1/2 FRENCH UMBILICAL VESSEL CATH. ETC.
- Applicant
- Superior Plastic Products Corp.
- Decision
- Substantially Equivalent
- Date received
- 1985-05-07
- Decision date
- 1985-06-18
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- FOZ
- Device class
- 2
- Regulation number
- 880.5200
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Cumberland, RI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.