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510(k) Data Aggregation
K Number
K041280Device Name
HUMAN SUBCUTANEOUS INJECTOR, MODEL HSI 500
Manufacturer
FELTON INTERNATIONAL, INC.
Date Cleared
2004-06-24
(42 days)
Product Code
KZE
Regulation Number
880.5430Why did this record match?
Applicant Name (Manufacturer) :
FELTON INTERNATIONAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This needle-free fluid injector system is indicated for the delivery of vaccines or medications to the subcutaneous tissue by penetrating the skin under high pressure. The device is to be used by a health care professional only.
Device Description
The Human Subcutaneous Injector system consists of a hand-held injector unit to which a multiple-dose vial of vaccine or medication can be attached. The unit is spring-powered and is connected to its hydraulic fluid power source, which is operated by a foot pump.
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K Number
K013256Device Name
BI-3M NEEDLE-FREE INJECTOR SYSTEM
Manufacturer
FELTON INTERNATIONAL, INC.
Date Cleared
2001-12-07
(67 days)
Product Code
KZE
Regulation Number
880.5430Why did this record match?
Applicant Name (Manufacturer) :
FELTON INTERNATIONAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This needle-free fluid injector system is indicated for the delivery of vaccines or medications to the subcutaneous tissue by penetrating the skin under high pressure. This device is to be used by a health care professional only.
Device Description
The Bi-3M Needle-Free Injector System consists of a hand-held injector unit to which a multiple-dose vial of vaccine or medication can be attached. The unit is spring-powered and is connected to its hydraulic fluid power source, which is operated by a foot pump.
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