LAC-MAC LIMITED

FDA Device Registration & Listing · LONDON Ontario, CA · Registration 8022129

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
8022129
FEI Number
6499
Entity Name
LAC-MAC LIMITED
City/State/Country
LONDON Ontario, CA
Establishment Address
847 HIGHBURY AVE, BUILDING No. 2, LONDON Ontario N5Y 5B8, CA
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device
Owner / Operator
LAC-MAC LIMITED (Owner Number: 8022129)
Owner / Operator Contact Address
847 HIGHBURY AVE, BUILDING #2, LONDON, CA-ON N5Y 5B8, CA
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K061491
PMA Number
N/A

All Registered Proprietary Names

Single Ply Wrapper Gown non-surgical R.MOR.Tex LR Surgical Gowns Gown, Surgical, Level 3 General purpose surgical drape, Reusable, Level 2 Surgical Drape, Level 4 R.MOR.Tex R.MOR.Tex

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2011-03-09
OEA Non-Surgical Gown General, Plastic Surgery Class 1 878.4040 2024-08-19
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2011-03-10
PUI Drape, Surgical, Exempt General, Plastic Surgery Class 2 878.4370 2022-03-01
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2007-11-06
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2007-11-06

Official Correspondent

No official correspondent registered.

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

LAC-MAC LIMITED
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
K892118 Paramount Products, Inc. NON-STERILE MASKS AND CAPS 1989-04-20
K914369 Deroyal Industries, Inc. QUALTEX MAGNETIC INSTRUMENT DRAPE 1991-12-02
K812809 Abco Dealers, Inc. STERILE ADHERENT DRAPES 1981-11-06
K910084 Biocor Medical, Inc. SURGICAL DRAPE 1991-03-19

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8022129. Last updated year: 2026. Please use registration number 8022129 when referencing this establishment in official correspondence.
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