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510(k) Data Aggregation
K Number
K152350Device Name
Regular and Special Umbilical Cord Clamp and Cutter
Manufacturer
Date Cleared
2016-06-28
(313 days)
Product Code
Regulation Number
884.4530Why did this record match?
Product Code :
NBZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Regular and Special Umbilical Cord Clamp and Cutter are intended for use in simultaneously clamping and cutting the umbilical cord of the new born baby at delivery
Device Description
"Regular and Special Umbilical Cord Clamp and Cutter" manufactured by "Ningbo Feite Medical Device Co., Ltd." are a single use, disposable, molded plastic device, unit packaged and sterile, intended to use for the simultaneously cut and clamp umbilical cord of the new born baby at delivery.
"Special Umbilical Cord Clamp and Cutter" are comprised of the exact same part as "Regular Umbilical Cord Clamp and Cutter", with the addition of an electronic clock. The time is automatically recorded when the cutting is performed.
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