Medical Device Manufacturer · US , MA

Louis M. Gerson Co., Inc. - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 1980

Recent clearances: RESPIRATOR N95 PARTICULATE RESPIRATOR, MODEL 1730, GERSON 2130/31 TYPE N95 NIOSH CERTIFIED SURGICAL RESPIRATOR, ISOLAIR APR TYPE N95

8

Total

8

Cleared

0

Denied

FDA 510(k) Regulatory Record - Louis M. Gerson Co., Inc. General Hospital ✕

8 devices

1-8 of 8

Cleared Nov 17, 2006

RESPIRATOR N95 PARTICULATE RESPIRATOR, MODEL 1730

General Hospital · 184d

Cleared Apr 11, 2005

GERSON 2130/31 TYPE N95 NIOSH CERTIFIED SURGICAL RESPIRATOR

General Hospital · 74d

Cleared May 09, 1996

ISOLAIR APR TYPE N95

General Hospital · 73d

Cleared Feb 03, 1994

ISOLAIR 2 FLUID RESIST SURG/PROCE/CONE/EARLOOP MAS

General Hospital · 477d

Cleared Jan 21, 1994

ISOLAIR 2 FULL FACE SPLASH GUARD

General Hospital · 315d

Cleared Nov 16, 1992

GERSON ISOLAIR APR PARTICULATE SURGICAL MASK

General Hospital · 173d

Cleared May 18, 1988

LABELING CHANGE TO SURGICAL FACE MASK

General Hospital · 19d

Cleared Nov 12, 1980

SURGICAL FACE MASK

General Hospital · 44d