THE LETHEAN COMPANY, LLC

FDA Device Registration & Listing · Chester Sprgs, PA, US · Registration 3020798191

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
3020798191
FEI Number
3020798191
Entity Name
THE LETHEAN COMPANY, LLC
City/State/Country
Chester Sprgs, PA, US
Establishment Address
1417 Birchrun Road, Chester Sprgs, PA 19425, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
The Lethean Company, LLC (Owner Number: 10083149)
Owner / Operator Contact Address
1417 Birchrun Road, Chester Springs, PA 19425, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

AirLock80 AirLock90 AirLock100

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
CAE Airway, Oropharyngeal, Anesthesiology Anesthesiology Class 1 868.5110 2021-10-28

Official Correspondent

Peter Eaton

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

The Lethean Company, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0002-2014 King Systems Corp. 1
King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3020798191. Last updated year: 2026. Please use registration number 3020798191 when referencing this establishment in official correspondence.
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