Regular and Special Umbilical Cord Clamp and Cutter
FDA 510(k) clearance K152350 · decided 2016-06-28
Clearance details
- K-number
- K152350
- Device name
- Regular and Special Umbilical Cord Clamp and Cutter
- Applicant
- Ningbo Feite Medical Device Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2015-08-20
- Decision date
- 2016-06-28
- Days to decision
- 313 days
- Clearance type
- Traditional
- Product code
- NBZ
- Device class
- 2
- Regulation number
- 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Ningbo, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.