JUFREY CORP. UNIV. DISPOS. SCALP VEIN INFUSION SET
FDA 510(k) clearance K853527 · decided 1985-09-23
Clearance details
- K-number
- K853527
- Device name
- JUFREY CORP. UNIV. DISPOS. SCALP VEIN INFUSION SET
- Applicant
- Jufrey Multimed Corp.
- Decision
- Substantially Equivalent
- Date received
- 1985-08-08
- Decision date
- 1985-09-23
- Days to decision
- 46 days
- Clearance type
- Traditional
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.