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510(k) Data Aggregation
K Number
K991680Device Name
SOFTINJECT
Manufacturer
Date Cleared
1999-06-03
(17 days)
Product Code
Regulation Number
880.6920Why did this record match?
Applicant Name (Manufacturer) :
ANDROSYSTEMS SRL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SOFTINJECT is an auto-injector indicated for assisting in the subcutaneous or intracorpus cavernosa injection of approved pharmaceutical products with approved commercially available syringes and needles.
Device Description
The SOFTINJECT is a syringe needle introducer, commonly known as an auto-injector. It is made of plastic molded parts and springs. The spring-loaded mechanism provides an injection with a hypodermic needle to a pre-determined depth below the skin surface. The SOFTINJECT is intended to be used with FDA-approved B-D 1 ml insulin syringes and approved needles filled with FDA-approved pharmaceutical products. The SOFTINJECT has been designed to assist in the subcutaneous or intracorpus cavernosa injection of pharmaceutical products.
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