LABELING CHANGE - VIASPAN(TM) (BELZER UW)
FDA 510(k) clearance K900492 · decided 1990-03-20
Clearance details
- K-number
- K900492
- Device name
- LABELING CHANGE - VIASPAN(TM) (BELZER UW)
- Applicant
- The DU Pont Co.
- Decision
- Substantially Equivalent
- Date received
- 1990-02-02
- Decision date
- 1990-03-20
- Days to decision
- 46 days
- Clearance type
- Traditional
- Product code
- KDL
- Device class
- 2
- Regulation number
- 876.5880
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Wilmington, DE, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.