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510(k) Data Aggregation
K Number
K073476Device Name
COMPACT AUTO-SAFETY INJECTOR (CASI)
Manufacturer
MEDICAL HOUSE (ASI) LIMITED
Date Cleared
2008-03-07
(88 days)
Product Code
KZH
Regulation Number
880.6920Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL HOUSE (ASI) LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Compact Auto Safety Injector (CASI) is indicated for assisting the selfadministered subcutaneous injection of fixed doses of FDA approved drug products with viscous liquid formulations, which are presented in standard 1ml long BD Hypak® pre-filled syringes with staked needles. The CASI is primarily intended for home use by patients to aid and support their treatment regime or may be used by Health Care Professionals or caregivers.
Device Description
The CASI is a single-use, automatic, disposable and hidden-needle auto-injector for the self-administration of liquid drug products.
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