POLYMED CHIRURGICAL INC.

FDA Device Registration & Listing · Saint-Laurent Quebec, CA · Registration 3004995451

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
3004995451
FEI Number
3004995451
Entity Name
POLYMED CHIRURGICAL INC.
City/State/Country
Saint-Laurent Quebec, CA
Establishment Address
387 Avenue Sainte-Croix, Saint-Laurent Quebec H4N2L3, CA
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
Polymed Chirurgical Inc. (Owner Number: 10080716)
Owner / Operator Contact Address
387 Avenue Sainte-Croix, Saint-Laurent, CA-QC H4N2L3, CA
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K170136
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
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2021-02-22
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2021-05-10
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2021-05-10

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Polymed Chirurgical 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
K201622 Guangdong Kingfa Sci. & Tech.Co., Ltd. Medical surgical mask 2020-11-24
K881618 3M Company ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK 1988-05-09
K212801 Hong Seng Gloves Sdn Bhd Powder free nitrile examination glove- black, non sterile 2022-01-09
K260806 Vista Industries,, LLC Nitrile Disposable Examination Gloves 2026-06-03
K011593 Ansell Healthcare Products, Inc. MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR BLUE NON-STERILE 2001-06-21

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004995451. Last updated year: 2026. Please use registration number 3004995451 when referencing this establishment in official correspondence.
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