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510(k) Data Aggregation
K Number
K230712Device Name
SG Lanset I, SG Lancets, Soft Lancets
Manufacturer
Sewon Medical Co.
Date Cleared
2023-12-06
(266 days)
Product Code
QRK, ORK
Regulation Number
878.4850Why did this record match?
Applicant Name (Manufacturer) :
Sewon Medical Co.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SG LANSET I, SG LANCETS and SOFT LANCETS are indicated to obtain a capillary blood sample from the side of a fingertip for testing utilizing small amounts of blood.
Device Description
The SG LANSET I, SG LANCETS and SOFT LANCETS are a single use, sterilized by gamma radiation, which is a pointed piece of surgical steel encased in plastic, used to puncture the skin on one's finger to get a blood sample. The SG LANSET I, SG LANCETS and SOFT LANCETS can be used anytime and anywhere to obtain a blood sample form diabetic patients to measure their blood sugar level. A cap is included to protect the needle from becoming contaminated with dust, etc. The cap completely seals the needle making it impossible for any foreign material to come in contact with the needle. This ensures safe storage and easy portability.
The lancing device used with most blood lancets, offers an adjustable tip with variety depth settings for quick, comfortable and easy blood sampling.
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