Data / Medical devices / United States / Louis M. Gerson Co., Inc.
Louis M. Gerson Co., Inc.: FDA-registered device maker in Middleboro, MA, United States, 1 510(k) clearance
Louis M. Gerson Co., Inc. is registered with the FDA (registration 1219752) in Middleboro, MA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated November 17, 2006. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1219752
- Address
- 16 Commerce Blvd, Middleboro, MA, United States, 02346
- Owner or operator
- LOUIS M. GERSON CO., INC. (1219752)
- Roles
- Manufacturer
- First device listed
- December 12, 2007
- Registered through
- 2026
- Brand names listed
- Louis M. Gerson Co. Inc. 1730, Louis M. Gerson Co. Inc. 3230+
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Respirator, Surgical | MSH | 2 | 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 |
|---|---|---|---|---|---|---|
| November 17, 2006 | K061375 | RESPIRATOR N95 PARTICULATE RESPIRATOR, MODEL 1730 | MSH | Substantially Equivalent | Louis M. Gerson Co., Inc. | accessdata.fda.gov |
Compare with other makers
Updated November 17, 2006. 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.