Louis M. Gerson Co., Inc.
Middleboro, MA, US
LOUIS M. GERSON CO., INC. appears in FDA device records in Middleboro, MA. FDA records list 8 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for Louis M. Gerson Co., Inc. between 1980 and 2006. The busiest year on record is 1994, with 2. The most recent is 2006, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1980 | 1 |
| 1988 | 1 |
| 1992 | 1 |
| 1994 | 2 |
| 1996 | 1 |
| 2005 | 1 |
| 2006 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K061375 | RESPIRATOR N95 PARTICULATE RESPIRATOR, MODEL 1730 | MSH | Substantially Equivalent | |
| K050193 | GERSON 2130/31 TYPE N95 NIOSH CERTIFIED SURGICAL RESPIRATOR | MSH | Substantially Equivalent | |
| K960778 | ISOLAIR APR TYPE N95 | MSH | Substantially Equivalent | |
| K925185 | ISOLAIR 2 FLUID RESIST SURG/PROCE/CONE/EARLOOP MAS | FXX | Substantially Equivalent | |
| K931288 | ISOLAIR 2 FULL FACE SPLASH GUARD | LYU | Substantially Equivalent | |
| K922507 | GERSON ISOLAIR APR PARTICULATE SURGICAL MASK | FXX | Substantially Equivalent | |
| K881910 | LABELING CHANGE TO SURGICAL FACE MASK | FXX | Substantially Equivalent | |
| K802373 | SURGICAL FACE MASK | FXX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1219752 | 1219752 | LOUIS M. GERSON CO., INC. | 16 Commerce Blvd, MIDDLEBORO, MA 02346 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain