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510(k) Data Aggregation
K Number
K982464Device Name
SCC-23 SAFETY CLAMP AND CUTTER
Manufacturer
WOMEN FIRST HEALTHCARE, INC.
Date Cleared
1998-08-11
(27 days)
Product Code
KNA, CLA
Regulation Number
884.4530Why did this record match?
Applicant Name (Manufacturer) :
WOMEN FIRST HEALTHCARE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SCC-23 Safety Clamp and Cutter is intended to simultaneously cut and clamp the umbilical cord following birth. The device reduces the risk to healthcare practitioners of unnecessary exposure to infection by bloodborne diseases.
Device Description
The SCC-23 Safety Clamp and Cutter is a pre-sterilized, ready-to-use, disposable obstetric instrument comprising a piston housing and two clamps manufactured of Polyamid 6.6 (nylon) which, upon incineration, converts to water vapor. The product also incorporates a stainless steel blade protectively sealed within the piston. The entire device weighs approximately 0.8 ounces or 23 grams. The clamp weighs approximately 0.1 ounces or 2.8 grams.
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