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510(k) Data Aggregation
K Number
K131661Device Name
INFUSION SYRINGE SET
Manufacturer
Date Cleared
2013-11-05
(151 days)
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
INNOVATIVE MEDICAL MANUFACTURING CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
IMM™ Infusion Syringe Set is intended for delivering controlled volume of fluids from reservoirs consistent with the labeled route of administration of fluids by manual operation.
Device Description
IMM 110 Infusion Syringe Set is single use product which contains disposable parts of one spike infusion set for connecting to fluid reservoir and fluid delivery, and a control syringe for delivery fluid supply from a solution bag to access device for purpose of delivering controlled volume of fluids from reservoirs consistent with the labeled route of administration of fluids by manual operation. The distal end of the set is a dual valve with 6% taper design for connecting to other access device such as needles before use. The IMM Infusion Syringe Set is provided sterile in fluid path, and to be disposed after single patient use.
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K Number
K090727Device Name
IMM DENTAL IRRIGATION TUBING SET
Manufacturer
Date Cleared
2009-08-13
(147 days)
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
INNOVATIVE MEDICAL MANUFACTURING CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The IMM™ Dental Irrigation Tubing Set is intended for providing passage of irrigating fluid from a solution reservoir to a dental handpiece.
Device Description
The IMM™ Dental Irrigation Tubing Set is to be used for providing passage of irrigating fluid t from a solution reservoir to a dental hand piece. The device consists of one or more inlet spikes, drip chamber, PVC plastic tubes, clamps, silicone tube, consists of only caps.
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K Number
K070801Device Name
IMM HYPODERMIC NEEDLE SET
Manufacturer
Date Cleared
2007-05-24
(62 days)
Product Code
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
INNOVATIVE MEDICAL MANUFACTURING CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The IMM Hypodermic Needle Set is to be used for sampling blood from or infusing fluid into body system underneath the skin.
Device Description
The IMM™ Hypodermic Needle Set consists of a conventional stainless steel needle, needle hub, extension tubing, clamp, and standard female 6% luer conical fitting for connection to a device contains a male luer fitting.
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