SCHNEIDER WALLSTENT(R)
FDA 510(k) clearance K911292 · decided 1991-05-01
Clearance details
- K-number
- K911292
- Device name
- SCHNEIDER WALLSTENT(R)
- Applicant
- Pfizer Hospital Products Group, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-03-25
- Decision date
- 1991-05-01
- Days to decision
- 37 days
- Clearance type
- Traditional
- Product code
- FGE
- Device class
- 2
- Regulation number
- 876.5010
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Plymouth, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.