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Lac Mac, Ltd.

FDA Regulatory Profile

Lac Mac, Ltd. has 0 FDA recalls, 3 inspections, 6 510(k) clearances and 1 compliance action on record.

What these totals cover: FDA records filed under the name "Lac Mac, Ltd." and its spelling variants "Lac Mac", "Lac-Mac Limited".

Latest inspection: Jul 11, 2024 · NAI
Latest 510(k): Jan 14, 2011

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Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	6	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	3	Nov 13, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

Recent FDA Inspections

3 inspections from Nov 6, 2014 to Jul 11, 2024.

Date	Site	Product	Classification	FEI
Jul 11, 2024	London, Canada	Devices	No Action Indicated (NAI)	6499
Nov 12, 2015	London, Canada	Devices	Voluntary Action Indicated (VAI)	6499
Nov 6, 2014	London, Canada	Devices	Official Action Indicated (OAI)	6499

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-Inspected Facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 6499	London, Canada	3	Jul 11, 2024

Recent 510(k) Clearances

6 510(k) clearances from May 6, 2003 to Jan 14, 2011.

K-Number	Device	Date
K102864	84E SERIES SINGLE PLY WRAPPER	Jan 14, 2011
K092344	LAC-MAC INNERBLOC LR SURGICAL GOWNS	Dec 17, 2009
K061491	LAC-MAC INNERBLOC O.R. GOWN	Aug 9, 2006
K032631	INNERBLOC LR SURGICAL GOWNS BASED ON GORE LR FABRIC (REUSABLE 100X)	Feb 5, 2004
K031362	LAC-MAC LIMITED INNERBLOC VARIOUS O.R. DRAPE BASED ON THE REPEL, PLUS AND GORE SURGICAL BARRIER…	May 30, 2003
K030536	LAC-MAC LIMITED INNERBLOC O.R. GOWN	May 6, 2003

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