Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007886187

FEI Number

3007886187

Entity Name

POLYNOVO BIOMATERIALS PTY LTD

City/State/Country

Port Melbourne Victoria, AU

Establishment Address

2/320 lorimer Street, Port Melbourne Victoria 3207, AU

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

PolyNovo Biomaterials Pty Ltd (Owner Number: 10046720)

Owner / Operator Contact Address

2/320 Lorimer Street, Port Melbourne, AU-VIC 3207, AU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K172140

PMA Number

N/A

All Registered Proprietary Names

NovoSorb® BTM NovoSorb® SynPath

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QSZ	Absorbable Synthetic Wound Dressing	Unknown	Class U	N/A	2017-09-13

Official Correspondent

Shruti Dave

US Agent Details

JOSEPH DEPAOLO Business: PolyNovo Email: polynallc@polynovo.com Phone: (760) 4485515

Related Public Records

Same Entity

PolyNovo Biomaterials Pty Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007886187. Last updated year: 2026. Please use registration number 3007886187 when referencing this establishment in official correspondence.