Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018382913

FEI Number

3018382913

Entity Name

623 MEDICAL

City/State/Country

Durham, NC, US

Establishment Address

4319 S Alston Ave Suite 100, Durham, NC 27713, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

623 Medical (Owner Number: 10081199)

Owner / Operator Contact Address

4319 S Alston Ave., Suite 100, Durham, NC 27713, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K202782

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MLY	Vapocoolant Device	Unknown	Class U	N/A	2021-03-24

Official Correspondent

Ty Schlander

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

623 Medical

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Similar Registrations

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3012448339	STERI-TEK	Fremont, CA, US
3021853802	VAPOCOOLSHOT, INC	Boca Raton, FL, US
3015177815	Hubot, Inc.	South Bend, IN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018382913. Last updated year: 2026. Please use registration number 3018382913 when referencing this establishment in official correspondence.