510(k) K152350
- Device
- Regular And Special Umbilical Cord Clamp And Cutter
- Applicant
- NINGBO FEITE MEDICAL DEVICE CO., LTD
- 510(k) number
- K152350
- Product code
- NBZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-06-28
- Date received
- 2015-08-20
- Regulation
- 884.4530
- Classification name
- Clamp And Cutter, Umbilical
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CHARLES SHEN
- Address
- Tongpenzha, Zhonggongmiao St., Yinzhou District Ningbo CN 315192 315192
FDA Registration Numbers#
- 3020298301
- 3005273623
- 3015060216
- 3008496560
- 3045058049
- 3003882387
Source Documents#
Legacy Summary#
summary
FDA Review#
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