ACU-MICRO-NEEDLE

Needle, Hypodermic, Single Lumen

ACUDERM, INC.

The following data is part of a premarket notification filed by Acuderm, Inc. with the FDA for Acu-micro-needle.

Pre-market Notification Details

Device IDK874024
510k NumberK874024
Device Name:ACU-MICRO-NEEDLE
ClassificationNeedle, Hypodermic, Single Lumen
Applicant ACUDERM, INC. 5370 N.W. 35TH TERRACE Ft. Lauderdale,  FL  33309
ContactCharles R Yeh
CorrespondentCharles R Yeh
ACUDERM, INC. 5370 N.W. 35TH TERRACE Ft. Lauderdale,  FL  33309
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-10-02
Decision Date1987-11-23

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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