EMMY MEDICAL, LLC

FDA Device Registration & Listing · Weston, MA, US · Registration 3010314836

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
3010314836
FEI Number
3010314836
Entity Name
EMMY MEDICAL, LLC
City/State/Country
Weston, MA, US
Establishment Address
84 Byron Rd, Weston, MA 02493, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Emmy Medical, LLC (Owner Number: 10048747)
Owner / Operator Contact Address
84 Byron Road, Weston, MA 02493, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

Kohli Atraumatic Catheter

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FAJ Cystoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2015-02-23
EZL Catheter, Retention Type, Balloon Gastroenterology, Urology Class 2 876.5130 2015-02-23
EZL Catheter, Retention Type, Balloon Gastroenterology, Urology Class 2 876.5130 2019-01-29

Official Correspondent

James Greenberg

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Emmy Medical, 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
K233013 Silq Technologies Corporation 2-Way 100% Silicone Cleartract Catheter 2024-01-23

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010314836. Last updated year: 2026. Please use registration number 3010314836 when referencing this establishment in official correspondence.
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