IUI CATHETER, MODEL 9057
FDA 510(k) clearance K052059 · decided 2005-11-22
Clearance details
- K-number
- K052059
- Device name
- IUI CATHETER, MODEL 9057
- Applicant
- Inntec, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-07-29
- Decision date
- 2005-11-22
- Days to decision
- 116 days
- Clearance type
- Abbreviated
- Product code
- MQF
- Device class
- 2
- Regulation number
- 884.6110
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Stoughton, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.