SIF-SW
FDA 510(k) clearance K904800 · decided 1991-03-27
Clearance details
- K-number
- K904800
- Device name
- SIF-SW
- Applicant
- Olympus Corp.
- Decision
- Substantially Equivalent
- Date received
- 1990-10-24
- Decision date
- 1991-03-27
- Days to decision
- 154 days
- Clearance type
- Traditional
- Product code
- FDA
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Lake Success, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.