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510(k) K162348

Device
ABCcolla Collagen Matrix
Applicant
ACRO BIOMEDICAL CO., LTD
510(k) number
K162348
Product code
KGN  
Decision
Substantially Equivalent (SESE)
Decision date
2017-05-10
Date received
2016-08-22
Regulation
510(k) Premarket Notification
Classification name
Dressing, Wound, Collagen
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
General & Plastic Surgery
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
DAR-JEN HSIEH
Address
3f., #57, Luke 2nd Rd., Lujhu Dist. Kaohsiung City TW 82151 82151

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KGN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261224MatriDermMedskin Solutions Dr. Suwelack AG2026-05-14
K260532Derma-GideGeistlich Pharma AG2026-03-19
K260218LacertaMatrixLacerta Life Sciences2026-02-19
K253140CollOvine™ Wound PowderOvigenex, LLC2026-02-10
K251323Device 104 ParticulateGeistlich Pharma AG2026-01-22
K253339TheracorStimlabs, LLC2025-12-22
K252673LacertaMatrixLacerta Life Science2025-12-22
K250864MatriDerm pluS+ Bi-LayerMedskin Solutions Dr. Suwelack AG2025-12-19
K242100SurgiAid Collagen Wound Dressing (HA)Maxigen Biotech, Inc.2025-10-16
K252001Collagen Wound DressingWinner Medical Co., Ltd.2025-10-10
K250397Helios Dermal ScaffoldHelios Biomedical, Inc.2025-08-15
K251845Marigen Wound Extra; Kerecis Silicone; Kerecis ParvusKerecis Limited2025-07-16
K250329GeniPhys Collymer Self-Assembling ScaffoldGeniphys, Inc.2025-06-25
K242985CollOvine™ Wound DressingOvigenex, LLC2025-06-20
K241904DermiSphere Dermal TemplateFesariustherapeutics, Inc.2025-01-06

Legacy Summary#

summary

FDA Review#

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