SPLIT TOP WING NEEDLE CAP WITH OPTIONAL TUBING ANCHORS (AND APPROPRIATE RECAP DEVICE

Needle, Hypodermic, Single Lumen

RESEARCHED, NOVEL MEDICAL DEVICES (RN/MD)

The following data is part of a premarket notification filed by Researched, Novel Medical Devices (rn/md) with the FDA for Split Top Wing Needle Cap With Optional Tubing Anchors (and Appropriate Recap Device.

Pre-market Notification Details

Device IDK944680
510k NumberK944680
Device Name:SPLIT TOP WING NEEDLE CAP WITH OPTIONAL TUBING ANCHORS (AND APPROPRIATE RECAP DEVICE
ClassificationNeedle, Hypodermic, Single Lumen
Applicant RESEARCHED, NOVEL MEDICAL DEVICES (RN/MD) 4480 SHERMAN OAKS CIRCLE Sherman Oaks,  CA  91403
ContactAnnabelle D Tucker
CorrespondentAnnabelle D Tucker
RESEARCHED, NOVEL MEDICAL DEVICES (RN/MD) 4480 SHERMAN OAKS CIRCLE Sherman Oaks,  CA  91403
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-09-22
Decision Date1995-01-31

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