Company ยท US
Louis M. Gerson Co., Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1980 to 2006. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 17, 2006 | K061375 | RESPIRATOR N95 PARTICULATE RESPIRATOR, MODEL 1730 Louis M. Gerson Co., Inc. | MSH |
| Apr 11, 2005 | K050193 | GERSON 2130/31 TYPE N95 NIOSH CERTIFIED SURGICAL RESPIRATOR Louis M. Gerson Co., Inc. | MSH |
| May 9, 1996 | K960778 | ISOLAIR APR TYPE N95 Louis M. Gerson Co., Inc. | MSH |
| Feb 3, 1994 | K925185 | ISOLAIR 2 FLUID RESIST SURG/PROCE/CONE/EARLOOP MAS Louis M. Gerson Co., Inc. | FXX |
| Jan 21, 1994 | K931288 | ISOLAIR 2 FULL FACE SPLASH GUARD Louis M. Gerson Co., Inc. | LYU |
| Nov 16, 1992 | K922507 | GERSON ISOLAIR APR PARTICULATE SURGICAL MASK Louis M. Gerson Co., Inc. | FXX |
| May 18, 1988 | K881910 | LABELING CHANGE TO SURGICAL FACE MASK Louis M. Gerson Co., Inc. | FXX |
| Nov 12, 1980 | K802373 | SURGICAL FACE MASK Louis M. Gerson Co., Inc. | FXX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||