TBD
FDA 510(k) clearance K910081 · decided 1991-07-15
Clearance details
- K-number
- K910081
- Device name
- TBD
- Applicant
- Empi
- Decision
- Substantially Equivalent
- Date received
- 1991-01-09
- Decision date
- 1991-07-15
- Days to decision
- 187 days
- Clearance type
- Traditional
- Product code
- KPI
- Device class
- 2
- Regulation number
- 876.5320
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Arden Hills, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.