GRIPPER MICRO NEEDLE

Needle, Hypodermic, Single Lumen

SMITHS MEDICAL MD, INC.

The following data is part of a premarket notification filed by Smiths Medical Md, Inc. with the FDA for Gripper Micro Needle.

Pre-market Notification Details

Device IDK072059
510k NumberK072059
Device Name:GRIPPER MICRO NEEDLE
ClassificationNeedle, Hypodermic, Single Lumen
Applicant SMITHS MEDICAL MD, INC. 1265 GREY FOX RD. Arden Hills,  MN  55112
ContactBrian L Haugstad
CorrespondentBrian L Haugstad
SMITHS MEDICAL MD, INC. 1265 GREY FOX RD. Arden Hills,  MN  55112
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-07-26
Decision Date2007-11-01
Summary:summary

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