SAPIMED DISPOSABLE SIGMOIDOSCOPE
FDA 510(k) clearance K070915 · decided 2007-07-06
Clearance details
- K-number
- K070915
- Device name
- SAPIMED DISPOSABLE SIGMOIDOSCOPE
- Applicant
- Sapimed S.P.A.
- Decision
- Substantially Equivalent
- Date received
- 2007-04-02
- Decision date
- 2007-07-06
- Days to decision
- 95 days
- Clearance type
- Traditional
- Product code
- KDM
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Crofton, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.