COMDEL INNOVATION, LLC

FDA Device Registration & Listing · Wahpeton, ND, US · Registration 3007361893

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
3007361893
FEI Number
3007361893
Entity Name
COMDEL INNOVATION, LLC
City/State/Country
Wahpeton, ND, US
Establishment Address
2100 15th St N, Wahpeton, ND 58075, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
ComDel Innovation, LLC (Owner Number: 10042112)
Owner / Operator Contact Address
2100 15th Street N, Wahpeton, ND 58075, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

NovoPulse TGS Field Generator Stand Air Alle' LouseBuster

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
ELZ Crown, Preformed Dental Class 1 872.3330 2019-10-30
PGW Ear, Nose, And Throat Stereotaxic Instrument Neurology Class 2 882.4560 2020-08-11
ISA Massager, Therapeutic, Electric Physical Medicine Class 1 890.5660 2018-03-13
QLV Field Generator Positioning Device Neurology Class 1 882.4565 2021-12-22
LJL Detectors And Removers, Lice, (Including Combs) General Hospital Class 1 880.5960 2012-10-22

Official Correspondent

Carter Hansen

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ComDel Innovation, 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
K200041 Fiagon GmbH FlexPointer 1.5 Single Use, FlexTube 3 Single Use 2020-03-10

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007361893. Last updated year: 2026. Please use registration number 3007361893 when referencing this establishment in official correspondence.
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