STERICAN HYPODERMIC NEEDLES

Needle, Hypodermic, Single Lumen

B. BRAUN MEDICAL, INC.

The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for Sterican Hypodermic Needles.

Pre-market Notification Details

Device IDK072247
510k NumberK072247
Device Name:STERICAN HYPODERMIC NEEDLES
ClassificationNeedle, Hypodermic, Single Lumen
Applicant B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown,  PA  18109 -9341
ContactChristine Ford
CorrespondentChristine Ford
B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown,  PA  18109 -9341
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-08-13
Decision Date2007-11-08
Summary:summary

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