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510(k) Data Aggregation
K Number
K042917Device Name
STAT MEDICAL PEN NEEDLE
Manufacturer
EMERGO GROUP, INC.
Date Cleared
2005-04-22
(182 days)
Product Code
FMI
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
EMERGO GROUP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Stat Medical Pen Needle is a single use device intended for use with a pen injector device for the subcutaneous injection of insulin.
Device Description
Stat Medical Pen Needle
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K Number
K032091Device Name
SMART KLAMP VARIOUS BY SIZE
Manufacturer
EMERGO GROUP, INC.
Date Cleared
2004-03-08
(245 days)
Product Code
HFX
Regulation Number
884.4530Why did this record match?
Applicant Name (Manufacturer) :
EMERGO GROUP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Circumcision of newborns and older males, defined as circumferential excision of the foreskin or prepuce at or near the level of coronal sulcus, with minimal amount of preputial skin remaining.
Device Description
The Smart Klarap® is a device composed of two components; a transparent plastic conic tube, and a plastic white clamping mechanism. The device is sold sterile for single use, packaged with a disposable sizing guide in a sterile pouch. The Smart Klamp® is available in multiple sizes, to accommodate newborn to adult patients.
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