Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9616227

FEI Number

3003320928

Entity Name

CORONEO, INC.

City/State/Country

MONTREAL, QC Quebec, CA

Establishment Address

9250 AVENUE DU PARC, SUITE 514, MONTREAL, QC Quebec H2N 1Z2, CA

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

CORONEO, INC. (Owner Number: 9040415)

Owner / Operator Contact Address

9250 AVENUE DU PARC, SUITE 514, --, MONTREAL, QC, CA-QC H2N 1Z2, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

COR-VALV SYSTEM COR-VASC SYSTEM

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2000-06-12
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2000-02-15

Official Correspondent

ANTHONY PAOLITTO

US Agent Details

David Hammond Email: daveh@hammondctc.com Phone: (206) 3833508

Related Public Records

Same Entity

CORONEO, INC.

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
K922626	Andronic Devices, Ltd.	ADEPT INSTRUMENT POSITIONING ACCESSORY	1992-10-19
K820290	The Anspach Effort, Inc.	SELF RETAINING RETRACTOR FOR HAND SURG	1982-03-05
K760422	Cutter Laboratories, Inc.	SURGICAL RETRACTOR	1976-08-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
Z-0008-04	Rultract Inc	1	Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.

Similar Registrations

Registration Number	Establishment Name	Location
3011050528	FREEHOLD SURGICAL, INC.	New Hope, PA, US
3021006167	KIMS MED CO., LTD.	Gwangju, KR
3045009502	WISDOM MEDICAL TECHNOLOGY (SHANGHAI) CO., LTD	Shanghai, CN
3032847175	BIOPHYX SURGICAL, INC.	Edgewater, MD, US
9681129	BEMA-GMBH & CO. KG	EMMINGEN Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616227. Last updated year: 2026. Please use registration number 9616227 when referencing this establishment in official correspondence.