ABCcolla Collagen Matrix

Dressing, Wound, Collagen

ACRO BIOMEDICAL CO., LTD

The following data is part of a premarket notification filed by Acro Biomedical Co., Ltd with the FDA for Abccolla Collagen Matrix.

Pre-market Notification Details

Device IDK162348
510k NumberK162348
Device Name:ABCcolla Collagen Matrix
ClassificationDressing, Wound, Collagen
Applicant ACRO BIOMEDICAL CO., LTD 3F., NO.57, LUKE 2ND RD, LUJHU DIST. Kaohsiung City,  TW 82151
ContactDar-jen Hsieh
CorrespondentDar-jen Hsieh
ACRO BIOMEDICAL CO., LTD 3F., NO.57, LUKE 2ND RD, LUJHU DIST. Kaohsiung City,  TW 82151
Product CodeKGN  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-08-22
Decision Date2017-05-10
Summary:summary

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