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510(k) Data Aggregation
K Number
K974288Device Name
ZEROWET SPLASHIELD
Manufacturer
ZEROWET, INC.
Date Cleared
1998-01-29
(76 days)
Product Code
KYZ
Regulation Number
880.6960Why did this record match?
Applicant Name (Manufacturer) :
ZEROWET, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Zerowet Splashield is intended for use as an accessory to an irrigation syringe. It is intended to be attached to the end of said syringe during wound irrigation, in place of the commonly used needle, thereby eliminating the use of a needle during this procedure. Additionally, the Zerower Splashield protects the user from contaminated (bloody) fluid splashing back during wound irrigation.
Device Description
The device of the current submission is an unsterilized styrene bell-shaped unit, with a 19g nozzle integrated in the stem which attaches to the end of a syringe. The intended use is as attached to the end of an irrigation syringe, during wound irrigation, to protect the user from (a) needlesticks (by eliminating the use of a needle), and (b) bloody splash during this procedure.
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