Data / Medical devices / Canada / Lac-Mac Limited
Lac-Mac Limited: FDA-registered device maker in LONDON Ontario, Canada, 4 510(k) clearances
Lac-Mac Limited is registered with the FDA (registration 8022129) in LONDON Ontario, Canada. It lists 5 device types. The FDA files 4 510(k) clearances under its listings, the newest dated January 14, 2011. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8022129
- FEI number
- 6499
- Address
- 847 HIGHBURY AVE BUILDING No. 2, LONDON Ontario, Canada, N5Y 5B8
- Owner or operator
- LAC-MAC LIMITED (8022129)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- November 6, 2007
- Registered through
- 2026
- Brand names listed
- General purpose surgical drape, Reusable, Level 2, Gown non-surgical, Gown, Surgical, Level 3, R.MOR.Tex, R.MOR.Tex LR Surgical Gowns, Single Ply Wrapper, Surgical Drape, Level 4
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Drape, Surgical, Antimicrobial | KKX | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Drape, Surgical, Exempt | PUI | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Gown, Surgical | FYA | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Wrap, Sterilization | FRG | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 14, 2011 | K102864 | 84E SERIES SINGLE PLY WRAPPER | FRG | Substantially Equivalent | Lac Mac, Ltd. | accessdata.fda.gov |
| December 17, 2009 | K092344 | LAC-MAC INNERBLOC LR SURGICAL GOWNS | FYA | Substantially Equivalent | Lac Mac, Ltd. | accessdata.fda.gov |
| August 9, 2006 | K061491 | LAC-MAC INNERBLOC O.R. GOWN | FYA | Substantially Equivalent | Lac Mac, Ltd. | accessdata.fda.gov |
| May 30, 2003 | K031362 | LAC-MAC LIMITED INNERBLOC VARIOUS O.R. DRAPE BASED ON THE REPEL, PLUS AND GORE SURGICAL BARRIER FABRIC MATERIALS | KKX | Substantially Equivalent | Lac Mac, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Non-Surgical Gown
- All makers of Wrap, Sterilization
- All makers of Drape, Surgical, Exempt
- All makers of Gown, Surgical
- All makers of Drape, Surgical, Antimicrobial
Updated January 14, 2011. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.