EM DEVICE LAB, INC.

FDA Device Registration & Listing · Austin, TX, US · Registration 3018387313

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
3018387313
FEI Number
3018387313
Entity Name
EM DEVICE LAB, INC.
City/State/Country
Austin, TX, US
Establishment Address
6303 Mountain Park Cv, Austin, TX 78731, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device
Owner / Operator
EM Device Lab, Inc. (Owner Number: 10081242)
Owner / Operator Contact Address
6303 Mountain Park Cv, Austin, TX 78731, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Quickloop Abscess Treatment Device

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GBX Catheter, Irrigation General, Plastic Surgery Class 1 878.4200 2021-04-13

Official Correspondent

Elisa Maldonado-Holmertz

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

EM Device Lab, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Similar Registrations

Registration Number Establishment Name Location
3032912826 KMD SURGICAL SOLUTIONS, INC. Winston Salem, NC, US
3017435705 CENTESE, INC. Omaha, NE, US
1057421 GRACE MEDICAL, INC. Memphis, TN, US
2521402 B. BRAUN MEDICAL INC. BETHLEHEM, PA, US
2246552 Isomedix Operations Inc. S Plainfield, NJ, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018387313. Last updated year: 2026. Please use registration number 3018387313 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.