NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER

Needle, Fistula

NIPRO MEDICAL CORPORATION

The following data is part of a premarket notification filed by Nipro Medical Corporation with the FDA for Nipro Biohole Needle With Capick Scab Remover.

Pre-market Notification Details

Device IDK100520
510k NumberK100520
Device Name:NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER
ClassificationNeedle, Fistula
Applicant NIPRO MEDICAL CORPORATION 3150 N.W. 107TH AVE. Miami,  FL  33172
ContactJessica Oswald
CorrespondentJessica Oswald
NIPRO MEDICAL CORPORATION 3150 N.W. 107TH AVE. Miami,  FL  33172
Product CodeFIE  
CFR Regulation Number876.5540 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-02-23
Decision Date2010-03-17
Summary:summary

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