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510(k) Data Aggregation
K Number
K071382Device Name
SCM CATH ( SIZES ARE VARYING BETWEEN 16G X 2'' AND 24G X 3/4'' ), MODEL 1.50, 1.77,1.88',2, 1.25, 1.50, 1.77,
Manufacturer
SHIN CHANG MEDICAL CO., LTD.
Date Cleared
2007-10-16
(152 days)
Product Code
FOZ
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
SHIN CHANG MEDICAL CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
An Intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short-term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously.
Device Description
a device that consists of a slender tube and any necessary connecting fittings
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K Number
K993017Device Name
PROFI DISPOSABLE SYRINGE, PROFI DISPOSABLE NEEDLE, DM JECT INSULIN SYRINGE
Manufacturer
SHIN CHANG MEDICAL CO., LTD.
Date Cleared
2000-02-25
(170 days)
Product Code
FMF
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
SHIN CHANG MEDICAL CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Hypodermic single lumen needle: Device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.
Piston Syringe: Device is used to inject fluids into, or withdraw fluids from the body.
Diabetic Insulin Syringe: Device intended to inject insulin below the surface of the skin.
Device Description
Not Found
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