Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010757045

FEI Number

3010757045

Entity Name

NEUROENTERPRISES LLC

City/State/Country

CHICAGO, IL, US

Establishment Address

11 E Walton St. Suite 3401, CHICAGO, IL 60611, US

Establishment Type(s)

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

Owner / Operator

NeuroEnterprises LLC (Owner Number: 10046392)

Owner / Operator Contact Address

11 E Walton St, Suite 3401, Chicago, IL 60611, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Neuro Enterprises Surgical Tray Chicago Tip Salehi Lumbar Foraminal Rasp

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2019-10-30
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2014-03-17
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2014-03-17

Official Correspondent

Sean Salehi

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

NeuroEnterprises 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
K881095	CooperVision, Inc.	KOI(TM) INSTRUMENT TRAYS	1988-04-06
K883982	Iberhospitex, S.A.	DRENOVAC	1989-02-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0036-2010	Alphatec Spine, Inc.	1	ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.
Z-0020-04	Vital Concepts, Inc.	1	Huntington Instruments brand Irrigation Aspiration System with Single Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55040. Labeled as Manufactured for Huntington Instruments, Ogden Utah.
Z-0021-04	Vital Concepts, Inc.	1	Irrigation Aspiration System with Double Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55060. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan. Huntington Instruments brand labeled as Manufactured for Huntington Instruments, Ogden Utah. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ. Catalogue # 55060-10 sold in Canada and labeled as Manufactured for Jac-Cell Medic, Dorval, Quebec.
Z-0022-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Irrigation Aspiration System with double Spike Tubing, no Probe, Disposable (single use only), sterile, latex free. Catalog # 55160. Vital Concepts, Inc., Grand Rapids, Michigan.
Z-0023-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Suction-Irrigation System without Probe, Disposable (single use only), sterile, latex free. R-Med Re-Order # 55170R; Distributed by R-Med, Inc., Orgeon, OH

Similar Registrations

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3002669946	Owens & Minor Distribution Inc. OM45	Sunrise, FL, US
1646747	WEXLER SURGICAL, INC.	HOUSTON, TX, US
1037577	ANGIOSYSTEMS, INC.	DUCKTOWN, TN, US
3016171961	HANGZHOU ALLINE PLASTIC CO., LTD.	HANGZHOU Zhejiang, CN
3007485169	MEDYSSEY CO., LTD.	Jecheon-si Chungbuk, KR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010757045. Last updated year: 2026. Please use registration number 3010757045 when referencing this establishment in official correspondence.