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510(k) Data Aggregation
K Number
K012121Device Name
SECUREGUARD RETRACTABLE SAFETY SYRINGE
Manufacturer
SAFEGARD MEDICAL PRODUCTS, INC.
Date Cleared
2001-10-24
(110 days)
Product Code
MEG
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
SAFEGARD MEDICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended function of the SECUREGARD® Retractable Safety Syringe is to provide a safe and reliable method of intramuscular and subcutaneous injection of medication into a patient. The syringe should not be used for blood collection. The SECUREGARD® Retractable Safety Syringe is also intended to prevent needle stick injuries. In addition, when the syringe user breaks the plunger, reuse of the syringe is prevented.
Device Description
The SECUREGARD is a sterile, single-use, disposable hypodermic syringe with sharps injury and reuse prevention features. It is manufactured in sizes of 0.5, 1, 2, 2.5, 3, 5, 10 and 20 mL volume.
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K Number
K012283Device Name
SOLOGARD LOCKING PLUS SYRINGE WITH NEEDLE
Manufacturer
SAFEGARD MEDICAL PRODUCTS, INC.
Date Cleared
2001-10-01
(73 days)
Product Code
FMI, FMF
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
SAFEGARD MEDICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
These syringes are intended for use by health care professionals for general purpose fluid aspiration/injection. The devices contain a piston locking mechanism which aids in the prevention of the accidental reuse of the syringe.
Device Description
The SOLOGARD® LOCKING PLUS Syringe is a sterile, single-use, disposable hypodermic syringe with a plunger locking feature to prevent the accidental reuse of the syringe. It is manufactured in sizes of 1, 2.5, 3, 5, & 10 ml and is supplied with a G29 x ½" or G29 x 5/8" needle.
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