COSTORSOL
FDA 510(k) clearance K091245 · decided 2009-06-17
Clearance details
- K-number
- K091245
- Device name
- COSTORSOL
- Applicant
- Preservation Solutions, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-04-28
- Decision date
- 2009-06-17
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- KDN
- Device class
- 2
- Regulation number
- 876.5880
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Denver, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.