DePre, LLC

FDA Device Registration & Listing · Powell, TN, US · Registration 3021190810

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
3021190810
FEI Number
3021190810
Entity Name
DePre, LLC
City/State/Country
Powell, TN, US
Establishment Address
227 DeBusk Lane, Powell, TN 37849, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device
Owner / Operator
DEROYAL INDUSTRIES, INC. (Owner Number: 1044833)
Owner / Operator Contact Address
200 DEBUSK LN., --, Powell, TN 37849, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Non-surgical Isolation Gown - DePre

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OEA Non-Surgical Gown General, Plastic Surgery Class 1 878.4040 2020-08-04

Official Correspondent

Elizabeth Reed

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

DEROYAL INDUSTRIES, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3008583452 DeRoyal Industries, Inc. Powell, TN, US
1051550 DEROYAL INDUSTRIES, INC. MAYNARDVILLE, TN, US
1057404 DeRoyal Industries, Inc. POWELL, TN, US
1034876 DEROYAL INDUSTRIES, INC. MAYNARDVILLE, TN, US
1055236 DEROYAL INDUSTRIES, INC. NEW TAZEWELL, TN, US

Similar Registrations

Registration Number Establishment Name Location
3044467533 TAROMED INC Los Angeles, CA, US
3016628950 BALUSTER LLC Mountain View, AR, US
3016760548 HEALTH SUPPLY US LLC Mooresville, NC, US
3013311664 UTOPIA TOWELS INC Plainview, NY, US
3021286079 PURCEL LABS LLC Los Angeles, CA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021190810. Last updated year: 2026. Please use registration number 3021190810 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.