Keneric Healthcare LLC

FDA Device Registration & Listing · Allen, TX, US · Registration 3013582868

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3013582868
FEI Number
3013582868
Entity Name
Keneric Healthcare LLC
City/State/Country
Allen, TX, US
Establishment Address
825 Watters Creek Boulevard, Suite 250, Allen, TX 75013, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device
Owner / Operator
Keneric Healthcare, LLC (Owner Number: 10045299)
Owner / Operator Contact Address
825 Watters Creek Boulevard, Suite 250, Allen, TX 75013, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K060832
PMA Number
N/A

All Registered Proprietary Names

RTD Wound Dressing

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FRO Dressing, Wound, Drug Unknown Class U N/A 2013-11-04

Official Correspondent

Gordon Wood

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Keneric Healthcare, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K150256 Argentum Medical SILVERLON BURN CONTACT DRESSINGS 2015-04-30

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0003-06 B. Braun Medical, Inc. U
D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025 3M Company Health Care Business 3m Center U
3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013582868. Last updated year: 2026. Please use registration number 3013582868 when referencing this establishment in official correspondence.
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