PANPAC UTERINE MANIPULATOR INJECTOR, MODEL UMI 4.5
FDA 510(k) clearance K092980 · decided 2010-03-11
Clearance details
- K-number
- K092980
- Device name
- PANPAC UTERINE MANIPULATOR INJECTOR, MODEL UMI 4.5
- Applicant
- Panpac Medical Corporation
- Decision
- Substantially Equivalent
- Date received
- 2009-09-28
- Decision date
- 2010-03-11
- Days to decision
- 164 days
- Clearance type
- Traditional
- Product code
- LKF
- Device class
- 2
- Regulation number
- 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Shi-Chih City, Taipei Hsien, TW
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.